Systems, devices, and methods for sample collection

ABSTRACT

Provided herein are systems, devices, and methods for sample collection. A sample collection device may comprise a vessel, a lid, and pre-loaded liquid solutions. The sample collection device may collect a liquid sample, such as a biological sample. The liquid solutions may comprise reagents for preserving and/or stabilizing biological samples, such as saliva, collected in the vessel. A chamber comprising the liquid solutions may be located in the vessel and/or the lid. In some instances, the liquid solution may be released from the chamber upon closure of the vessel with the lid. In some instances, the liquid solution may be released from the chamber upon actuation of an implement, such as a plunger. In some instances, the liquid solution may be released upon compression of an absorbent member. The sample collecting device may be delivered to a remote location for further processing and/or analysis.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to U.S. Application No.62/569,082, filed on Oct. 6, 2017, which is incorporated by referenceherein in its entirety for all purposes.

BACKGROUND

Bodily fluids, such as saliva, sweat, urine, and blood, can be collectedfrom a subject and analyzed to determine information contained in suchsamples of bodily fluids. For example, a sample may contain informationpertaining to the subject. The sample may contain information pertainingto the environment inhabited by the subject. In some instances, thesamples may comprise deoxyribonucleic acid (DNA) molecules that can befurther processed and/or analyzed to determine genetic information aboutthe subject.

Saliva is a bodily fluid generally secreted by the major salivaryglands, such as the parotid, submandibular, and sublingual glands.Saliva may be collected non-invasively, such as by expelling directlyfrom the mouth or inserting a collector, such as a swab, in the mouth tocollect.

SUMMARY

On-site collection of biological samples, while relatively safe andguaranteeing a certain standard, can be inconvenient for severalreasons. For example, a subject may have to travel a long distance toreach an on-site center (e.g., labs, hospitals, clinics, etc.), wastingvaluable time, expenses, and other resources for a sample collectionprocedure that can be relatively simple especially for the types ofsamples (e.g., saliva) that can be collected non-invasively. For manysubjects, no on-site center may be reasonably accessible. Furthermore,biological samples collected remotely and delivered to a lab for furtherprocessing or analysis are prone to contamination, spoiling, leakage,and/or loss which can present difficulties during such analysis, whichcan affect the cost of analysis, as well as both the speed and accuracyof the results. Thus recognized herein is a need for systems, devices,and methods for sample collection that can safely and securely deliver abiological sample between remote locations while preserving theintegrity of the sample. There is a need for simple systems, devices,and methods that permit non-sophisticated users to collect a biologicalsample for delivery to a remote location.

Provided herein are systems, devices, and methods for sample collection.A sample collection device may comprise a vessel, a lid, and pre-loadedliquid solutions. The liquid solutions may comprise reagents thatpreserve and/or stabilize liquid samples collected in the vessel. Theliquid solution may comprise other reagents. The liquid samples cancomprise biological samples. A biological sample can be, for example,saliva. The biological sample can be sputum or spit. A chambercomprising the liquid solution (e.g., reagent) may be located in thevessel and/or the lid. In some instances, the reagent may be releasedfrom the chamber upon closure of the vessel with the lid. In someinstances, the reagent may be released from the chamber upon actuationof an implement (e.g., plunger). The implement may be movable. In someinstances, the reagent may be released upon compression of an absorbentmember. The sample collection device may, such as through one or more ofthe abovementioned mechanisms, bring in contact or into fluidcommunication the liquid solution and the liquid sample. The samplecollecting device, once securely closed, may be delivered to a remotelocation for further processing and/or analysis of the preserved and/orstabilized (or otherwise processed) sample.

Additional aspects and advantages of the present disclosure will becomereadily apparent to those skilled in this art from the followingdetailed description, wherein only illustrative embodiments of thepresent disclosure are shown and described. As will be realized, thepresent disclosure is capable of other and different embodiments, andits several details are capable of modifications in various obviousrespects, all without departing from the disclosure.

Accordingly, the drawings and description are to be regarded asillustrative in nature, and not as restrictive.

In one embodiment, a device for storing a liquid sample, comprises: acap comprising one or more inner walls and a first engagement unit; anda vessel comprising a first set of one or more walls defining a cavitycomprising an open end and a closed end, and a second engagement unitadjacent to said open end, wherein said second engagement unit iscapable of engaging with said first engagement unit, and wherein saidcavity comprises: an implement that comprises a second set of one ormore walls at least partially defining a reservoir for storing saidliquid sample, wherein said second set of one or more walls comprises atleast one opening through which said reservoir is in fluid communicationwith said cavity; and a chamber at least partially defined by said firstset of one or more walls, said closed end of said cavity, and saidsecond set of one or more walls, wherein said chamber comprises a liquidsolution, wherein said implement is movable along an axis of said cavitybetween (i) a first position and (ii) a second position, whereinmovement of said implement from said first position to said secondposition subjects said liquid solution to flow from said chamber to saidreservoir; and wherein upon said first engagement unit engaging withsaid second engagement unit, said cap closes said open end and subjectssaid implement to movement along said axis from said first position tosaid second position, thereby subjecting said liquid solution to flowfrom said chamber to said reservoir.

In one embodiment of the device, portions of said first set of one ormore walls that are at or adjacent to said closed end comprise one ormore serrations or protrusions.

In one embodiment of the device, at said second position, said secondset of one or more walls interfaces with said one or more serrations orprotrusions to disrupt a barrier between said first set of one or morewalls and said second set of one or more walls.

In one embodiment of the device, at said first position, said second setof one or more walls interfacing with said first set of one or wallsforms a barrier between said chamber and said reservoir through a seal.

In one embodiment of the device, at said first position, said second setof one or more walls interfaces with said one or more serrations orprotrusions to seal said chamber from said reservoir.

In one embodiment of the device, said second set of one or more wallsinterfacing with said one or more serrations or protrusions seals saidchamber through an interference fit.

In one embodiment of the device, said first engagement unit and saidsecond engagement unit are a pair of complementary threads.

In one embodiment of the device, said implement is configured to lock atsaid second position.

In one embodiment of the device, said chamber has a first volume at saidfirst position and a second volume at said second position, and whereinsaid first volume is greater than said second volume.

In one embodiment of the device, said axis is a vertical axis of saidvessel.

In one embodiment of the device, at said first position, said chambercomprises said liquid solution in an amount that substantially fillssaid chamber.

In one embodiment of the device, said liquid sample is a biologicalsample.

In one embodiment of the device, said liquid solution is a reagent forstabilizing said biological sample.

In one embodiment of the device, the device further comprises a funnelcomprising a first end, a second end, and a third engagement unitadjacent to said first end, wherein said third engagement unit iscapable of removably engaging with said second set of one or more walls,and upon engagement of said third engagement unit, said second end isbrought into fluid communication with said reservoir.

In one embodiment of the device, said third engagement unit isconfigured to pinch together a given wall of said first set of one ormore walls and a given wall of said second set of one or more walls.

In one embodiment of the device, upon engagement of said thirdengagement unit, said vessel and said implement are fixed relative tothe other.

In one embodiment of the device, said third engagement unit comprises aclip configured to surround said given wall of said first set of one ormore walls and said given wall of said second set of one or more walls.

In one embodiment of the device, upon engagement of said thirdengagement unit, said funnel seals said at least one opening in saidimplement, thereby fluidically isolating said chamber and saidreservoir.

In one embodiment of the device, the device further comprises acontainer for shipping said device, wherein said container comprises acavity that is dimensioned to receive and retain said device duringshipping.

In one embodiment, a device for storing a liquid sample comprises: a capcomprising (i) a shell comprising a first engagement unit, (ii) a platecomprising at least one aperture, and (iii) a chamber at least partiallydefined by said plate, wherein said chamber comprises an absorbentmatrix comprising a liquid solution, wherein said liquid solution isreleasable from said absorbent matrix upon compression of said absorbentmatrix; and a vessel comprising (i) one or more walls at least partiallydefining a reservoir for storing said liquid sample, and (ii) acompression unit that is configured to interface with said plate,wherein said vessel comprises a second engagement unit configured toengage with said first engagement unit, wherein upon said firstengagement unit engaging with said second engagement unit, said capcloses said vessel and said compression unit interfaces with said plateto subject said absorbent matrix to compression, thereby releasing saidliquid solution from said absorbent matrix through said at least oneaperture to said reservoir.

In one embodiment of the device, said compression unit is part of saidone or more walls.

In one embodiment of the device, said chamber is at least partiallydefined by said shell.

In one embodiment of the device, said first engagement unit and saidsecond engagement unit are a pair of complementary threads.

In one embodiment of the device, said absorbent matrix is saturated withsaid liquid solution.

In one embodiment of the device, said absorbent matrix is not saturatedwith said liquid solution.

In one embodiment of the device, said plate is movable into saidchamber.

In one embodiment of the device, said plate is movable with a limiteddegree of freedom.

In one embodiment of the device, said plate is movable into said chamberby at most 5 cm.

In one embodiment of the device, said plate is movable into said chamberin a substantially vertical direction.

In one embodiment of the device, said liquid sample is a biologicalsample.

In one embodiment of the device, said liquid solution is a reagent forstabilizing said biological sample.

In one embodiment of the device, the device further comprises acontainer for shipping said device, wherein said container comprises acavity that is dimensioned to receive and retain said device duringshipping.

In one embodiment, a method for collecting and storing a liquid sample,comprises using an embodiment of any of the devices described above tocollect said liquid sample from a subject.

In one embodiment, a method for processing a liquid sample, comprisessteps of:

-   (a) receiving a device as in any of the above embodiments, which    device comprises said liquid sample collected from a subject;    and (b) processing said liquid sample from said device.

In one embodiment of the method, said processing comprises subjectingsaid liquid sample to nucleic acid amplification.

In one embodiment of the method, said nucleic acid amplificationcomprises reverse transcription amplification and/or polymerase chainreaction.

In one embodiment of the method, said liquid sample comprisesdeoxyribonucleic acid (DNA), ribonucleic acid (RNA), and/or protein fromsaid subject.

In one embodiment of the method, said processing comprises subjecting anucleic acid and/or protein sample derived from said liquid sample tosequencing to determine a sequence of said nucleic acid and/or proteinsample.

In one embodiment, a kit for collecting and storing a liquid sample,comprising: an embodiment of any of the devices described above; andinstructions for directing a user to collect said liquid sample from asubject and store said liquid sample in said device. Said instructionsmay be provided on a physical medium accompanying said device or in anelectronic medium, or both.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.To the extent publications and patents or patent applicationsincorporated by reference contradict the disclosure contained in thespecification, the specification is intended to supersede and/or takeprecedence over any such contradictory material.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings (also “Figure” and “FIG.” herein) of which:

FIG. 1A shows a cross-sectional view of a sample collection device in anunengaged position, according to an embodiment.

FIG. 1B shows a cross-sectional view of the sample collection device ofFIG. 1A in an engaged position, according to an embodiment.

FIG. 2A shows a cross-sectional view of another sample collection devicein an open position, according to an embodiment.

FIG. 2B shows a cross-sectional view of the sample collection device ofFIG. 2A in a closed position, according to an embodiment.

FIG. 3A shows a cross-sectional view of another sample collection devicein an open position, according to an embodiment.

FIG. 3B shows a cross-sectional view of the sample collection device ofFIG. 3A in a closed position, according to an embodiment.

FIG. 4 shows a cross-sectional view of another sample collection devicein an open position, according to an embodiment.

FIG. 5A shows a cross-sectional view of another sample collection devicein a funneled position, according to an embodiment.

FIG. 5B shows a perspective view of a funnel of the sample collectiondevice of FIG. 5A, according to an embodiment.

FIG. 5C shows a cross-sectional view of the sample collection device ofFIG. 5A in an open position, according to an embodiment.

FIG. 5D shows a perspective view of a vessel of the sample collectiondevice of FIG. 5A, according to an embodiment.

FIG. 6A shows a cross-sectional view of another sample collection devicein an open position, according to an embodiment.

FIG. 6B shows a cross-sectional view of the sample collection device ofFIG. 6A in a closed position, according to an embodiment.

DETAILED DESCRIPTION

While various embodiments of the invention have been shown and describedherein, it will be obvious to those skilled in the art that suchembodiments are provided by way of example only. Numerous variations,changes, and substitutions may occur to those skilled in the art withoutdeparting from the invention. It should be understood that variousalternatives to the embodiments of the invention described herein may beemployed.

The term “sample,” as used herein, generally refers to a specimen forprocessing and/or analysis. A sample may be a liquid sample. A samplemay be a fluid (e.g., gas, liquid) sample.

A sample may be a biological sample. The sample may be a bodily fluid.In an example, the bodily fluid is saliva, sputum, blood, perspiratoryfluid (e.g., sweat), pus, tear, mucosal excretion, vomit, urine, stool,semen, vaginal fluids, or other type of bodily fluid. The sample can bea non-fluid sample. The sample can be a cell-free sample, such as acell-free nucleic acid sample. The sample can include cell-freedeoxyribonucleic acid (DNA), cell-free ribonucleic acid (RNA), and/orcell-free protein. The sample can include one or more cells (e.g.,circulating tumor cells).

The sample can be a solid or tissue sample. The sample can be a skinsample. The sample can be a cheek swab or a swab of a different bodilypart. The sample can be a homogenous sample or a heterogeneous sample.The sample can be a tumor sample, for instance. The sample can includeone or more types of different biological samples (e.g., saliva and skintissue). The sample may be derived from another sample. The sample canbe a plasma or serum sample.

Alternatively or in addition to, the sample can be a non-biologicalsample (e.g., soil sample). Any description herein of any specific typeof sample, such as sputum or saliva, may apply to any other type ofsample.

The term “engagement unit,” as used herein, generally refers to one ormore features that are configured to engage with one or more otherfeatures. Examples of engagement units include, without limitation, oneor more threads, interference fitting, hooks and loops, latches, screws,staples, clips, clamps, prongs, rings, brads, rubber bands, rivets,grommets, pins, ties, snaps, velcro, adhesives, tapes, vacuum, seals, ora combination thereof. SYSTEMS, DEVICES, AND METHODS FOR SAMPLECOLLECTION

A sample may be collected from a subject and preserved and/or stabilizeduntil such time of further processing and/or analysis, such as bycontacting, or otherwise being exposed to, one or more reagents. Forexample, the collected sample, or one or more components thereof, may bepreserved in their original state until such time of further processingand/or analysis. The collected sample, or one or more componentsthereof, may be preserved and/or stabilized to prevent bacterial orfungal growth. The collected sample may be preserved for at least 1hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 12 hours, 1 day, 2days, 3 days, 4 days, 5 days, 6 days,

7 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2 months, 3 months,4 months, 5 months, 6 months, 1 year, 2 years, 3 years, or for longerdurations. The collected sample may be preserved and stored at roomtemperature or lower for prolonged periods of time, such as duringtransit and/or storage. The collected sample may be preserved and storedat ambient temperatures or lower for prolonged periods of time, such asto ensure preservation during transit (e.g., shipping warehouses, etc.)and/or storage. Alternatively or in addition, the collected sample maybe preserved at temperatures of up to about 60° Celsius (° C.).

As used herein, a reagent may refer to any kind of substance acting onthe collected sample to achieve a desired effect. The reagent may be inany suitable form, such as a fluid (e.g., liquid, gas, solution, etc.)or a non-fluid (e.g., solid powder, etc.). In some instances, thereagent can be configured to preserve deoxyribonucleic acid (DNA),ribonucleic acid (RNA), proteins, or other components of proteins in thesample. In some instances, the reagent can be configured to prevent oneor more cells from having their antigens degraded and/or preventalterations in the cellular epigenome of one or more cells. The reagentmay permit extraction of one or more constituents (e.g., nucleic acidmolecules) from a cell from the collected sample. The reagent may beconfigured to otherwise process the collected sample and/or one or moreconstituents thereof. A liquid solution may comprise one or morereagents configured to achieve one or more desired affects.

Beneficially, the systems, devices, and methods provided herein mayfacilitate convenient and simple at-home, on-site, or remote collectionof samples. Non-sophisticated users, and even minors, may be capable ofcollecting samples without direct supervision. Users of a samplecollection device may advantageously be shielded from direct exposure tochemical reagents, which may or may not be toxic, that are pre-loaded inthe sample collection device at any point during the sample collectionprocess. In some instances, users may be provided with easy-to-followinstructions. The instructions may instruct on how to use a device,collect a sample using the device, dispose (e.g., ship to a remotelocation) of the device after use, access results from analysis of thesample, or other instructions. The collected sample may be transported,such as via shipping (e.g., through the mail or a carrier), to a remotelab for further processing and/or analysis.

The stabilized and/or preserved sample can be further processed andanalyzed at an outside facility (e.g., remote facility). For example,nucleic acids (e.g., DNA, etc.) from the sample can be isolated andextracted for amplification and/or sequencing applications.

Reference is now made to the figures. It will be appreciated that thefigures and features therein are not necessarily drawn to scale.

FIG. 1A shows a cross-sectional view of a sample collection device 100in an unengaged position. FIG. 1B shows a cross-sectional view of thesample collection device 100 in an engaged position. The samplecollection device 100 can comprise a vessel 102 and a plunger 104 thatis insertable in the vessel 102. The vessel 102 can comprise one or morewalls 106 that define a reservoir 108 for receiving a biological sample150 and a reagent chamber 110 to hold a preservation reagent 160. Theone or more walls can be formed of a polymeric material (e.g.,polypropylene, polystyrene, polycarbonate, etc.), metallic material(e.g., aluminum), and/or composite material. The reservoir 108 and thereagent chamber 110 can be separated by an integral web 112. In someinstances, the integral web 112 can be a part of the one or more walls106. Alternatively or in addition, the integral web 112 can be aseparate structure fastened to the one or more walls 106. The integralweb 112 can have an aperture 114 through which the reservoir 108 and thereagent chamber 110 are in fluid communication. The reservoir 108 canhave an opening 116 to receive the biological sample 150 from a user.The user may be a subject from whom the sample is collected. Forexample, the user can spit into the reservoir 108 through the opening.The reagent chamber 110 can comprise an opening 118.

The plunger 104 can comprise a first end 120 and a second end 122. Thefirst end 120 can be configured to seal the opening 118 of the reagentchamber 110 to prevent the reagent 160 from leaving the reagent chamber110 through the opening 118. For example, the first end 120 can comprisea lower gasket 124 that spans an inner cross-section of the reagentchamber 110.

The lower gasket 124 can have an interference fit to the innerdimensions of the reagent chamber 110 and provide a fluid-tight seal toprevent the reagent 160 from reaching or passing through the opening118. The seal can be a hermetic seal. Any description herein of aplunger may apply to any other implement, such as a rod, stage, plate,or other actuator.

The first end 120 can be configured to enter the reagent chamber 110through the opening 118 when the plunger 104 is injected into the vessel102. The lower gasket 124 may continue to seal the opening 118, such asvia the interference fit, as the plunger 104 is injected into the vessel102. That is, the reagent 160 can be contained in the reagent chamber110 between the lower gasket 124 and the integral web 112.

The second end 122 can be configured to seal the aperture 114 in theintegral web 112 to prevent the reagent 160 from entering the reservoir108 through the aperture 114 and prevent the biological sample 150 fromentering the reagent chamber 110 through the aperture 114. For example,the second end 122 can comprise an upper gasket 126 at its tip thatspans a cross-section of the aperture 114. The upper gasket 126 can havean interference fit to the aperture 114 and provide a fluid-tight sealto fluidically isolate the reservoir 108 from the reagent chamber 110when the upper gasket 126 is in place. The seal can be a hermetic seal.

The second end 122 can be configured to enter the reservoir 108 throughthe aperture 114 when the plunger 104 is injected into the vessel 102.The seal (e.g., interference fit) from the upper gasket 126 can bebroken (or released) as the tip of the second end 122 having the uppergasket 126 passes the aperture 114. When the seal is broken, thereservoir 108 and the reagent chamber 110 can be in fluid communicationwith the other. That is, the biological sample 150 may enter the reagentchamber 110 and/or the reagent 160 may enter the reservoir 108 to form amixture 170 of the biological sample 150 and the reagent 160. When theplunger 104 is fully injected into the vessel 102, the lower gasket 124may reach the integral web 112 such that the mixture 170 is directedinto the reservoir 108.

In some instances, the plunger 104 may not be removed from the vessel102 by the user. For example, a cross-section of a pre-inserted part ofthe first end 120 of the plunger 120 may be larger than a cross-sectionof the opening 118 of the reagent chamber 110.

The opening 116 of the reservoir 108 can be closed by a cap or lid (notshown) that is fastened or coupled to the vessel 102, such as to the oneor more walls 106 of the vessel 102, to cover the opening 116. Fasteningor coupling can be achieved by engagement units, such as via fasteningor coupling mechanisms. Example of engagement units include, but are notlimited to, complementary threading, form-fitting pairs, interferencefitting, hooks and loops, latches, screws, staples, clips, clamps,prongs, rings, brads, rubber bands, rivets, grommets, pins, ties, snaps,velcro, adhesives, tapes, vacuum, seals, or a combination thereof. Anydescription herein of any specific type of fasteners, engagement units,fastening mechanisms, coupling mechanisms, or engagement mechanisms,such as threads or threading, may apply to any other type of fasteners,engagement units, fastening mechanisms, coupling mechanisms, orengagement mechanisms. For example, a cap with threads fastened to avessel with complementary threads by threading to close the vessel maybe interchanged with a stopper fastened to the vessel via form-fittingseal to close the vessel. The cap may seal the vessel 102. The seal canbe fluid-tight. The seal can be a hermetic seal.

In application, the device 100 is provided to the user in an unengagedposition (as in FIG. 1A). The reagent 160 is pre-loaded in the reagentchamber 110 and the plunger 104 is disposed in the vessel 102 such thatthe upper gasket 126 is sealing the aperture 114 in the integral web 112and the lower gasket 124 is sealing the opening 118 in the reagentchamber 110. The plunger 104 is insertable into the vessel 102. The userspits or otherwise deposits the biological sample 150 into the reservoir108 through the opening 116.

The user can close the opening 116 of the reservoir 108 with a cap orlid (not shown). Thereafter, the biological sample 150 is sealed in thereservoir 108 and fluidically isolated from the reagent compartment 110,and the reagent 160 is sealed in the reagent compartment 110 andfluidically isolated from the reservoir 108. The user then applies aforce to inject the plunger 104 into the vessel 102. In an example, thiscan be accomplished by using one or more hands to push or press theplunger 104 inwards. In another example, this can be accomplished byholding the vessel 102 and pushing the plunger 104 end of the vessel 102against any surface (e.g., floor, wall, desk surface, etc.). Onceinjected, the seal of aperture 114 is broken (or released) and thereservoir 108 and the reagent chamber 110 are brought in fluidcommunication with each other. The biological sample 150 and the reagent160 form a mixture 170 of the biological sample 150 and the reagent 160.

When the plunger 104 is fully injected (as in FIG. 1B), the lower gasket124 reaches the integral web 112, and the mixture 170 is directed intothe reservoir 108. In some instances, once injected, the plunger 104 canlock in the injected position such that the mixture 170 stays in thereservoir 108. In other instances, after injection, the plunger 104 canbe uninjected, and the mixture 170 can freely travel between thereservoir 108 and the reagent chamber 110. The plunger 104 may not beremoved from the vessel 102 by the user. For example, a cross-section ofa pre-inserted part of the first end 120 of the plunger 120 may belarger than a cross-section of the opening 118 of the reagent chamber110.

The user may transport the device 100, such as via shipping, to a remotelocation such as an outside lab for further processing and/or analysis.The device 100 may be shipped in a container with or without insulation.For example, the container can be an envelope, packaging, and/or a box.The device 100 may withstand routine forces received in shippingenvironments.

In some instances, the user may inject the plunger 104 before closingthe opening 116 of the reservoir 108 with the cap or lid. In someinstances, the user may inject the plunger 104 before depositing thebiological sample 150 in the reservoir 108.

In some instances, the integral web 112 can have a plurality ofapertures, and the plunger 104 can have corresponding structures andcomponents (e.g., plurality of gaskets) to seal the plurality ofapertures. In some instances, the reagent compartment 110 can have aplurality of openings, and the plunger 104 can have correspondingstructures and components (e.g., plurality of gaskets) to seal theplurality of openings.

In some instances, in the unengaged position (as in FIG. 1A) the reagentchamber 110 may be fully pre-loaded with the reagent 160 to fill thereagent chamber 110. Alternatively, the reagent chamber 110 may bepartially pre-loaded with the reagent 160.

In some instances, the one or more walls 106 of the vessel 102 maycomprise one or more markings corresponding to fluid volume forreference to users (e.g., sample origin, lab technician, etc.) of thedevice 100. For example, one or more markings may correspond to a volumeof the reagent 160 in the reagent compartment 110. One or more markingsmay correspond to a volume of the biological sample 150 in the reservoir108. One or more marking may correspond to a volume of the mixture 170in the reservoir 108. In some instances, at least a part of the one ormore walls 106 of the vessel may be at least partially transparentand/or translucent, or clear, to permit visual recognition of the one ormore markings.

While FIGS. 1A and 1B illustrate a device with the reservoir 108 and thereagent chamber 110 as vertically neighboring compartments, otherconfigurations are available where the reservoir 108 and the reagentchamber 110 are fluidically communicating through the aperture 114. Forexample, the reservoir 108 and the reagent chamber 110 can behorizontally neighboring compartments, diagonally neighboringcompartments, or placed relative to the other in any other orientationwith an aperture 114 fluidically connecting the two compartments.

In some instances, the aperture 114 can define a fluid path, such as astraight and/or curved cross-sectional path and the plunger 104 can havea corresponding structure to seal the aperture 114 and/or enter theaperture 114. For example, the aperture 114 can have a curvature, andthe second end 122 can have a corresponding curvature to travel throughthe aperture 114. In some instances, the reagent chamber 110 can definea straight or curved path for the plunger 104 to be injected in, and theplunger 104 can have a corresponding structure to seal the opening 118and/or enter the reagent chamber 110. For example, the path can have acurvature, and the first end 120 can have a corresponding curvature totravel through the path.

In some instances, the user can deposit the biological sample 150 intothe reservoir 108 on a carrier. For example, the carrier can be anabsorbent member, such as a swab, cotton, pad, sponge, foam, or othermaterial or device capable of carrying the biological sample 150 byabsorbing. When the reagent 160 is directed to the reservoir 108 byactuation of the plunger 104, the absorbent member may absorb thereagent 160, thereby contacting the biological sample 150 therein withthe reagent 160 to preserve and/or stabilize the biological sample 150.The carrier can be other materials or device capable of carrying thebiological sample 150 in a location that is in fluid communication withthe reservoir 108 such as to allow the reagent 160 to contact thebiological sample 150 on the carrier.

In an example, the user uses the device 100 to collect the biologicalsample 150 (e.g., saliva or cheek swab) from a subject. The user can bethe subject. Alternatively, the user can be one or more otherindividuals (e.g., supervisor, guardian, lab technician, worker, etc.)that collect the biological sample 150 from the subject. The biologicalsample 150 is deposited into the sample reservoir 108 through theopening 116. Next, the user actuates the plunger 104, such as by pushingthe plunger 104 into the vessel 102. The reagent 160 is directed intothe reservoir 108 and forms a mixture 170 with the biological sample150. The user closes the opening 116 with a lid (not shown). The closeddevice 100 is then transported (e.g., via mail), such as to a remote labfor further processing and/or analysis. The biological sample 150 ispreserved and/or stabilized during such transportation with aid of thereagent 160.

Any description herein of a biological sample (e.g., biological sample150) with reference to the device 100 can apply to a liquid sample. Anydescription herein of a reagent (e.g., reagent 160) with reference tothe device 100 can apply to a liquid solution. For example, the device100 may be pre-loaded with a liquid solution and facilitate collectionof a liquid sample.

FIG. 2A shows a cross-sectional view another sample collection device200 in an open position. FIG. 2B shows a cross-sectional view of thesample collection device 200 in a closed position. The sample collectiondevice 200 can comprise a vessel 202 and a lid 204.

The vessel 202 can comprise one or more walls 206 that define areservoir 208 for receiving a biological sample 250 from a user. Theuser may be a subject from whom the sample is collected. The one or morewalls 206 can comprise a first lid engagement unit 210, such as threads,to couple with the lid 204. The vessel 202 can comprise a second lidengagement unit 211, such as a rod or beam (wherein FIG. 2A shows across-section of a rod or beam which length is extending into theplane), to couple with the lid 204.

The lid 204 can comprise an outer shell 212, an inner wall 214, and asleeve 216. The outer shell 212 can be fused or otherwise fastened to aninner wall 214. When fastened, the inner wall 214 can be fixed relativeto the outer shell 212. The outer shell 212 and the inner wall 214 canenclose and define a reagent chamber 218. The reagent chamber 218 cancomprise a preservation and/or stabilization reagent 260 for preservingand/or stabilizing the biological sample 250. The inner wall 214 cancomprise an aperture 220 through which the reagent 260 may leave thereagent chamber 218.

The inner wall 214 can be mechanically assembled or otherwise fastenedto a sleeve 216. A surface (e.g., bottom surface) of the inner wall 214can interface a surface (e.g., top surface) of the sleeve 216. Whenfastened, the surface of the inner wall 214 may rotate relative to thesurface of the sleeve 216 while interfacing the surface of the sleeve216. In some instances, the inner wall 214 may rotate relative to thesleeve 216 only when sufficient torque is applied, such as to overcomefrictional resistance. For example, this frictional resistance can beprovided by a sealant 225, adhesive, or other material disposed betweenthe inner wall 214 and the sleeve 216. The resistance can be provided bya mechanical element (e.g., stopper, blocking unit) in the mechanicalassembly of the inner wall 214 and the sleeve 216. In some instances,the inner wall 214 may rotate relative to the sleeve 216 only when amechanical trigger is engaged (e.g., removal of a blocking unit, etc.).

The sleeve 216 can comprise a first vessel engagement unit 222, such asthreads complementary to the first vessel engagement unit 210. Thesleeve 216 can comprise a second vessel engagement unit 223, such as adepression complementary to the second lid engagement unit 211. Thesleeve 216 can comprise an aperture 224. In some instances, the sealant225 can be disposed between the interfacing surface of the inner wall214 and the interfacing surface of the sleeve 216 to provide afluid-tight seal between the two surfaces such that fluid does not seepbetween the interfacing surfaces. The seal can be a hermetic seal. Forexample, the sealant 225 can be a silicone coating.

In an open position (as in FIG. 2A), the sleeve 216 can be mechanicallyassembled to the inner wall 214 such that the first aperture 220 in theinner wall 214 is blocked by a surface (e.g., top surface) of the sleeve216 and the second aperture 224 in the sleeve 216 is blocked by asurface (e.g., bottom surface) of the inner wall 214. Because the firstaperture 220 is blocked by the sleeve 216, the reagent 260 isfluidically confined to the reagent compartment 218 defined by the outershell 212 and the inner wall 214.

To alternate to the closed position (as in FIG. 2B), the vessel 202 canbe closed with the lid 204 by coupling the first vessel engagement unit222 with the first lid engagement unit 210, such as via a threadingmotion. As the lid 204 descends to cover the vessel 202, the secondvessel engagement unit 223 in the sleeve 216 can engage with the secondlid engagement unit 211 in the vessel 202 to fix the sleeve 216 inposition relative to the vessel 202. When the sleeve 216 is fixedrelative to the vessel 202, a continued threading motion of the lid 204can provide sufficient torque to rotate the inner wall 214 (and thefixed outer shell 212) relative to the sleeve 216. As the inner wall 214rotates relative to the sleeve 216, the first aperture 220 in the innerwall 214 can at least partly align with the second aperture 224 in thesleeve 216 to bring the reagent chamber 218 in fluid communication withthe reservoir 208. When the first aperture 220 and the second aperture224 at least partly align, the reagent 260 in the reagent chamber 218can flow into the reservoir 208 to form a mixture 270 with thebiological sample 250. The biological sample 250 can thereby bepreserved and/or stabilized in the mixture 270.

In application, the user is provided the device 200 in an open position(as in FIG. 2A). The reagent 260 is pre-loaded in the reagent chamber218 in the lid 204 and fluidically isolated from the reservoir 208 orany other space external to the lid 204. The inner wall 214 and thesleeve 216 are mechanically assembled such that the sleeve 216 isblocking the aperture 220 of the inner wall 214. In some instances, thesealant 225 is disposed between the interfacing surfaces of the innerwall 214 and the sleeve 216 to provide a fluid tight seal in theinterface of the inner wall 214 and the sleeve 216. The user spits orotherwise deposits the biological sample 250 into the reservoir 208through an opening of the reservoir 208 in the vessel 202.

The user can close the vessel 202 with the lid 204. As the lid 204 isbrought in proximity to the vessel 202, the first lid engagement unit210 (e.g., threads) in the vessel 202 engages the first vesselengagement unit 222 (e.g., complementary threads) in the lid 204. Thelid 204 descends with a threading motion until the second lid engagementunit 211 (e.g., rod, beam, etc.) in the vessel 202 engages the secondvessel engagement unit 223 (e.g., depression) in the lid 204. Theengagement of the second lid engagement unit 211 and the second vesselengagement unit 223 fixes the sleeve 216 relative to the vessel 202. Asthe user continues the threading motion on the lid 204, the user appliesa sufficient torque to rotate the inner wall 214 (and the rest of thelid 204 assembly) relative to the sleeve 216. Upon rotation of the innerwall 214 relative to the sleeve 216, the aperture 220 in the inner wall214 and the aperture 224 in the sleeve 216 at least partially align,thereby bringing into fluid communication the reagent chamber 218 andthe reservoir 208. The reagent 260 flows into the reservoir 208 to forma mixture 270 of the reagent 260 and the biological sample 250. Thebiological sample 250 can thereby be preserved and/or stabilized in themixture 270. In some instances, the reagent 260 may flow into thereservoir 208 via gravitational forces.

Thereafter, the lid 204 is fastened to the vessel 202 and the mixture270 is confined in the reservoir 208 and optionally in the reagentcompartment 218 which is in fluid communication with the reservoir 208.In some instances, the user may twist or rotate the lid 204 relative tothe vessel 202 in some amount (e.g., 180°) in a direction opposite tothe direction of closing to rotate the inner wall 214 relative to thesleeve 216 such that the aperture 224 in the sleeve 216 is blocked bythe inner wall 214 and the mixture 270 is fluidically isolated in thereservoir 208.

The user may transport the device 200, such as via shipping, to a remotelocation such as an outside lab for further processing and/or analysis.The device 200 may be shipped in a container with or without insulation.For example, the container can be an envelope, packaging, and/or a box.The device 200 may withstand routine forces received in shippingenvironments.

In some instances, the user can deposit the biological sample 250 intothe reservoir 208 on a carrier. For example, the carrier can be anabsorbent member, such as a swab, cotton, pad, sponge, foam, or othermaterial or device capable of carrying the biological sample 250 byabsorbing. When the reagent 260 flows in the reservoir 208, theabsorbent member may absorb the reagent 260, thereby contacting thebiological sample 250 therein with the reagent 260 to preserve and/orstabilize the biological sample 250. The carrier can be other materialsor device capable of carrying the biological sample 250 in a locationthat is in fluid communication with the reservoir 208 such as to allowthe reagent 260 to contact the biological sample 250 on the carrier.

In some instances, the inner wall 214 and the sleeve 216 may bemechanically assembled such that the inner wall 214 may rotate relativeto the sleeve 216 with a limited degree of freedom. For example, theinner wall 214 may rotate relative to the sleeve 216 at most by 3 turns(1080°), 2.5 turns (900°), 2 turns (720°), 1.5 turns (540°), 1 turn(360°), 330°, 300°, 270°, 240°, 210°, 180°, 150°, 140°, 130°, 120°,110°, 100°, 90°, 80°, 70°, 60°, 50°, 40°, 30°, 20°, 10°, 5°, or less. Insome instances, the inner wall 214 and the sleeve 216 may bemechanically assembled such that the inner wall 214 may rotate relativeto the sleeve 216 in either direction (e.g., clockwise, andcounterclockwise). Alternatively, the inner wall 214 and the sleeve 216may be mechanically assembled such that the inner wall 214 may rotaterelative to the sleeve 216 in only one direction (e.g., clockwise,counterclockwise).

In some instances, the inner wall 214 can comprise a plurality ofapertures, such as 2, 3, 4, 5, 6, 7, 8, 9, 20, or more apertures. Thesleeve 224 can comprise an appropriate number of apertures to bring thereagent chamber 218 in fluid communication with the reservoir 208through the plurality of apertures in the inner wall 214 when the device200 is in a closed position.

In some instances, in the open position (as in FIG. 2A) the reagentchamber 218 may be fully pre-loaded with the reagent 260 to fill thereagent chamber 210. Alternatively, the reagent chamber 218 may bepartially pre-loaded with the reagent 260.

In some instances, the one or more walls 206 of the vessel 202 maycomprise one or more markings corresponding to fluid volume forreference to users (e.g., sample origin, lab technician, etc.) of thedevice 200. For example, one or more markings may correspond to a volumeof the biological sample 250 in the reservoir 208. One or more markingmay correspond to a volume of the mixture 270 in the reservoir 208. Insome instances, at least a part of the one or more walls 206 of thevessel 202 may be at least partially transparent and/or translucent, orclear, to permit visual recognition of the one or more markings. In someinstances, the outer shell 212 of the lid 204 may comprise one or moremarkings corresponding to fluid volume for reference to users (e.g.,sample origin, lab technician, etc.) of the device 200. For example, oneor more markings may correspond to a volume of the reagent 260 in thereagent compartment 210. In some instances, at least a part of the outershell 212 of the lid 204 may be at least partially transparent and/ortranslucent, or clear, to permit visual recognition of the one or moremarkings.

In some instances, the lid 204 may be coupled to the vessel 202 via oneor more other coupling or fastening mechanisms described elsewhereherein. As an example, the inner diameter of the sleeve 216 may form-fitthe outer diameter of the vessel 202 and allow fastening of the twocomponents without need for a threading motion or threading features,and the inner wall 214 may rotate relative to the sleeve 216 to openand/or close fluid communication between the reagent chamber 218 and thereservoir 208. As another example, the locations of the threads may beinverted such that the threads are on the inner walls of the vessel 202and on the outer walls of the sleeve 216 and the sleeve 216 threadsinside the vessel 202. In such a case, the inner wall 214 and outershell 212 may be outside the vessel 202 when in a closed position.

In an example, the user uses the device 200 to collect the biologicalsample 250 (e.g., saliva or cheek swab) from a subject. The user can bethe subject. Alternatively, the user can be one or more otherindividuals (e.g., supervisor, guardian, lab technician, worker, etc.)that collect the biological sample 250 from the subject. The biologicalsample 250 is deposited into the reservoir 208. Next, the user closesthe vessel 202 with the lid 204, such as by engaging (e.g., threading)the lid 204 with the vessel 202. Upon engagement, the first aperture 220and the second aperture 224 at least partially align, bringing thereagent chamber 218 in fluid communication with the reservoir 208. Thereagent 260 is directed into the reservoir 208 through the first andsecond apertures 220, 224 and forms a mixture 270 with the biologicalsample 250. The closed device 200 is then transported (e.g., via mail),such as to a remote lab for further processing and/or analysis. Thebiological sample 250 is preserved and/or stabilized during suchtransportation with aid of the reagent 260.

Any description herein of a biological sample (e.g., biological sample250) with reference to the device 200 can apply to a liquid sample. Anydescription herein of a reagent (e.g., reagent 260) with reference tothe device 200 can apply to a liquid solution. For example, the device200 may be pre-loaded with a liquid solution and facilitate collectionof a liquid sample.

FIG. 3A shows a cross-sectional view of another sample collection device300 in an open position. FIG. 3B shows a cross-sectional view of thesample collection device 300 in a closed position. The sample collectiondevice 300 can comprise a lid 302, a vessel 304, and an implement 306.

The lid 302 can comprise a first vessel engagement unit 308 and a secondvessel engagement unit 310. The first vessel engagement unit 308, forexample, can be threads. The second vessel engagement unit 310, forexample, can be a protrusion configured to contact one or morecomponents of the vessel 304 and/or the implement 306.

The vessel 304 can comprise one or more walls 312 that define a cavity314 with an open end and a closed end. The one or more walls 312 cancomprise a first lid engagement unit 315. The first lid engagement unit315, for example, can comprise threads complementary to the first vesselengagement unit 310. The one or more walls 312 can comprise one or moreserrations 313 facing or emanating into the inside of the cavity 314located at and/or in proximity to the closed end or the bottom of thevessel. The number of serrations and distance between serrations mayoptionally be varied depending on the size (e.g., length and diameter)of the vessel and/or the size of the serrations. For example, if thevessel is configured to have a larger diameter at the closed end orbottom, more serrations may be included. The number of serrations may befrom 1 to 6, 4 to 10, 8 to 16, 14 to 20, 18 to 40, 30 to 60, 40 to 100,90 to 120, 100 to 150, 125 to 175, 150 to 200, 175 to 300, 200 to 400,or more, depending on the size of serrations. Alternatively, the numberof serrations may be outside the above-recited ranges. The serrations313 can be located at about 10 centimeters (cm), 9 cm, 8 cm, 7 cm, 6 cm,5 cm, 4 cm, 3 cm, 2 cm, 1 cm, or less, or 10 millimeters (mm), 9 mm, 8mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or less, distance from theinner wall of the closed end. Alternatively, the serrations 313 may belocated more than 10 cm distance from the inner wall of the closed end.In some cases, the location of the serrations may depend on the size(e.g., length) of the vessel.

The serrations 313 can be micro-serrations. In some instances, theserrations 313 can be protrusions or micro-protrusions. The serrations313 and/or protrusions can have sharp, jagged, and/or cutting edges.Alternatively or in addition, the serrations 313 can have rounded edges.In some instances, the serrations 313 can be molded or otherwiseintegrated in the one or more walls 312. Alternatively or in addition,the serrations 313 can be separate structures fastened to be fixed tothe one or more walls 312.

The implement 306 can be displaceable, injectable, plungeable,retractable, dejectable, ascendible, descendible, and/or otherwise bemovable or actuated relative to the vessel 302. For example, theimplement 306 can be a plunger. The implement 306 can be a secondvessel, tube or vial. The implement 306 can be a rod, stage, plate, orother actuator. Any description herein of a plunger may apply to anyother implement, such as a rod, stage, plate, or other actuator.

The implement 306 can be disposed in the cavity 314. The implement 306can be insertable in the cavity 314 towards the closed end. Theimplement 306 can comprise a base plate 316, one or more sidewalls 318,and a second lid engagement unit 320. The one or more sidewalls 318 andthe baseplate 316 can define a reservoir 322 for receiving a biologicalsample (not shown) from a user. In some instances, the baseplate 316 canbe part (e.g., an integral part, a monolithic part, etc.) of the one ormore sidewalls 318. The baseplate 316 can be located towards the closedend of the cavity 314. The baseplate 316 can be flat, curved, or haveany other surface profile. The user may be a subject from whom thesample is collected. The one or more sidewalls 318 can comprise one ormore openings 324 through which the reservoir 322 and the cavity 314 arein fluid communication. The second lid engagement unit 320 can engagewith the second vessel engagement unit 310 of the lid 302. In someinstances, the second lid engagement unit 320 can be part of the one ormore sidewalls 318 of the implement 306. During closing of the vessel304, the second vessel engagement unit 310 (e.g., protrusion) of the lid302 can apply a force (e.g., via push, press) on the second lidengagement unit 320 (e.g., sidewall perimeter) to actuate the implement306 and inject the implement 306 towards the closed end of the cavity314.

The base plate 316 can span the cross-section of the cavity 314 toprovide a seal 325 between the base plate 316 and the non-serratedportions of the one or more walls 312 defining the cavity 314. The seal325 can be a wiper seal. The seal 325 can be a fluid-tight seal. Theseal 325 can be a hermetic seal. The seal 325 can be provided via aninterference fit between the outer dimension of the base plate 316 andthe inner dimension of the one or more walls 316. The base plate 316 andthe one or more walls 316 may comprise the same or different materials(e.g., polypropylene and polyethylene, etc.). The seal 325 can bemaintained between the non-serrated (or non-protruded) portion of theone or more walls 312 as the implement 306 is injected (or dejected).

Thus, the base plate 316 can partition the cavity 314 to define areagent chamber 326 that is fluidically isolated from the remainder ofthe cavity 314. The base plate 316 and the one or more walls 312 at orin proximity to the closed end of the cavity 314 can define the reagentchamber 326. The reagent chamber 326 can be fluidically isolated fromthe reservoir 322 which is in fluid communication with the rest of thecavity 314. The reagent chamber 326 can comprise a preservation and/orstabilization reagent 360.

When the device 300 is in an open position (as in FIG. 3A), the baseplate 316 can be located above the serrated and/or protruded portion ofthe one or more walls 312 such that the seal 325 is intact and thereagent chamber 326 is fluidically isolated from the reservoir 322.

To alternate the device 300 to the closed position (as in FIG. 3B), thelid 302 can be brought in proximity to the vessel 304. The first vesselengagement unit 308 (e.g., threads) in the lid 302 can engage with thefirst lid engagement unit 315 (e.g., complementary threads) in thevessel 304 to couple the lid 302 and the vessel 304. For example, thelid 302 can descend onto the vessel 304 in a threading motion. As thelid 302 descends, the second vessel engagement unit 310 (e.g.,protrusion) in the lid 302 can engage the second lid engagement unit 320(e.g., sidewall perimeter) of the implement 306, and translate thedescending motion to actuate the implement 306 and inject the implement306 towards the closed end of the cavity 314 of the vessel 302.

As the implement 306 is injected, the base plate 316 of the implementcan continue to provide the seal 325 between the one or more walls 312of the vessel 302 and the base plate 316 until the base plate 316engages the one or more serrations 313 on the one or more walls 312 ofthe vessel 302 and the seal 325 is disrupted. For example, theprotrusions and/or serrations may reduce the contact area of the seal325 to bring the reagent chamber 326 in fluid communication with theremainder of the cavity 314 and, by extension, to the reservoir 322 viathe one or more openings 324. As the implement 306 is injected, and thereagent chamber 326 decreases in volume, the reagent 360 may flow aroundthe disrupted seal 325 into the cavity 314 and into the reservoir 322 toform a mixture 370 of the biological sample (not shown) and the reagent360. The reagent 360 may preserve and/or stabilize the biological samplein the mixture 370.

In application, the device 300 is provided to the user in an openposition (as in FIG. 3A). The reagent 360 is pre-loaded in the reagentchamber 326 and the implement 306 is disposed in the vessel 304 suchthat the base plate 316 is interfacing a non-serrated portion of the oneor more walls 312 and the seal 325 is intact. The implement 306 isinsertable into the vessel 304. The user spits or otherwise deposits thebiological sample (not shown) into the reservoir 322 through an opening328 of the reservoir 322. In some instances, the opening 328 of thereservoir 322 can be the only opening to the vessel 304. The biologicalsample and the reagent 360 are fluidically isolated.

The user can close the opening 328 of the reservoir 322 with the lid302, such as by engaging the first vessel engagement unit 308 of the lid302 and the first lid engagement unit 315 of the vessel 304. Upondescent of the lid 302, the second vessel engagement unit 310 of the lid302 can engage the second lid engagement unit 320 of the implement 308,and the implement 308 can be injected towards the closed end of thecavity 314. Once injected, the base plate 316 of the implement 306engages the one or more serrations 313 on the one or more walls 312 ofthe vessel 304 and the seal 325 is disrupted. The reagent chamber 326and the remaining cavity 314 space are brought into fluid communication.As the implement decreases the volume of the reagent chamber 326, thereagent 360 escapes the reagent chamber 326 around or through thedisrupted seal 325 to enter the remaining cavity 314 space andthereafter enter the reservoir 322 through the one or more openings 324on the one or more sidewalls 318 of the implement 306.

The biological sample and the reagent 360 form a mixture 370 of thebiological sample and the reagent 360. The reagent 360 can preserveand/or stabilize the biological sample in the mixture 370. The mixture370 may be stored in the reservoir 322 and/or the cavity 314.

The device 300 can be configured such that the implement 306 is fullyinjected (as in FIG. 3B) when the lid 302 is securely fastened to thevessel 304. When the implement 306 is fully injected, the base plate 316may contact the closed end of the cavity 314 such that there issubstantially no volume in the reagent chamber 326 and as a result allof the reagent 360 comes in contact with the biological sample to formthe mixture 370. Alternatively, when the lid 302 is securely fastened tothe vessel 304, the implement 306 may be partially injected, and thebase plate 316 may not necessarily contact the closed end of the cavity314.

In some instances, once injected, the implement 306 can lock in theinjected position such that it cannot be dejected and the mixture 370stays in the reservoir 322 and/or cavity 314 space above the base plate316. In other instances, after injection, the implement 306 can beun-injected (or dejected), such as when the lid 302 is removed and themixture 370 may travel between the reservoir 322, cavity 314, and/or thereagent chamber 326. In some instances, the implement 306 may not beremoved from the vessel 304 by the user. For example, a cross-section ofa pre-inserted part of the implement 306 may be larger than across-section of the open end of the cavity 314.

In some instances, the seal 325 may re-seal after disruption when thebase plate 316 returns to interfacing a non-serrated portion of the oneor more walls 312 of the vessel 304. Alternatively, the seal 325 mayremain disrupted even after the base plate 316 returns to interfacing anon-serrated portion of the one or more walls 312 of the vessel 304.

The user may transport the closed device 300, such as via shipping, to aremote location such as an outside lab for further processing and/oranalysis. The device 300 may be shipped in a container with or withoutinsulation. For example, the container can be an envelope, packaging,and/or a box. The device 300 may withstand routine forces received inshipping environments.

In some instances, in the open position (as in FIG. 3A) the reagentchamber 326 may be fully pre-loaded with the reagent 360 to fill thereagent chamber 326. Alternatively, the reagent chamber 326 may bepartially pre-loaded with the reagent 360.

In some instances, the one or more walls 312 of the vessel 304 or othercomponents of the vessel 304 and/or the implement 306 may comprise oneor more markings corresponding to fluid volume for reference to users(e.g., sample origin, lab technician, etc.) of the device 300. Forexample, one or more markings may correspond to a volume of the reagent360 in the reagent compartment 326. One or more markings may correspondto a volume of the biological sample in the reservoir 322. One or moremarking may correspond to a volume of the mixture 370 in the reservoir322 and/or the cavity 314. In some instances, at least a part of the oneor more walls 312 of the vessel may be at least partially transparentand/or translucent, or clear, to permit visual recognition of the one ormore markings. In some instances, at least a part of the othercomponents of the vessel 304 and/or the implement 306 can be at leastpartially transparent and/or translucent, or clear, to permit visualrecognition of the one or more markings.

While FIGS. 3A and 3B illustrate a device with the reservoir 322 and thereagent chamber 326 as generally vertically neighboring compartments,other configurations are available. For example, the reservoir 322 andthe reagent chamber 326 can be horizontally neighboring compartments,diagonally neighboring compartments, or placed relative to the other inany other orientation relative to the cavity 314.

In some instances, the user can deposit the biological sample into thereservoir 322 on a carrier. For example, the carrier can be an absorbentmember, such as a swab, cotton, pad, sponge, foam, or other material ordevice capable of carrying the biological sample by absorbing. When thereagent 360 is directed to the reservoir 322 by actuation of theimplement 306, the absorbent member may absorb the reagent 360, therebycontacting the biological sample therein with the reagent 360 topreserve and/or stabilize the biological sample. The carrier can beother materials or device capable of carrying the biological sample in alocation that is in fluid communication with the reservoir 322 such asto allow the reagent 360 to contact the biological sample on thecarrier.

In an example, the user uses the device 300 to collect the biologicalsample (e.g., saliva or cheek swab) from a subject. The user can be thesubject. Alternatively, the user can be one or more other individuals(e.g., supervisor, guardian, lab technician, worker, etc.) that collectthe biological sample from the subject. The biological sample isdeposited into the reservoir 322 through the opening 328. Next, the usercloses the vessel 304 with the lid 302, such as by engaging (e.g.,threading) the lid 302 with the vessel 304. Upon engagement, the lid 302actuates the implement 306, such as by pushing the implement 306 inwardsthe vessel 304. Actuation of the implement 306 brings the reagentchamber 326 in fluid communication with the reservoir 322. The reagent360 is directed into the reservoir 322 and forms a mixture 370 with thebiological sample. The closed device 300 is then transported (e.g., viamail), such as to a remote lab for further processing and/or analysis.The biological sample is preserved and/or stabilized during suchtransportation with aid of the reagent 360.

Any description herein of a biological sample with reference to thedevice 300 can apply to a liquid sample. Any description herein of areagent (e.g., reagent 360) with reference to the device 300 can applyto a liquid solution. For example, the device 300 may be pre-loaded witha liquid solution and facilitate collection of a liquid sample.

FIG. 4 shows a cross-sectional view of another sample collection device400 in an open position. The sample collection device 400 can comprise alid 402, a vessel 404, and an implement 406.

The lid 402 can comprise a first vessel engagement unit 408 and a secondvessel engagement unit 410. The first vessel engagement unit 408, forexample, can be threads. The second vessel engagement unit 410, forexample, can be a protrusion configured to contact one or morecomponents of the vessel 404 and/or the implement 406.

The vessel 404 can comprise one or more walls 412 that define a cavity414 with an open end and a closed end. The one or more walls 412 cancomprise a first lid engagement unit 415. The first lid engagement unit415, for example, can be threads complementary to the first vesselengagement unit 410. The one or more walls 412 can comprise one or moreprotrusions 413 facing the inside of the cavity 414 located in proximityto the closed end. For example, the protrusions 413 can be located atmost 10 centimeters (cm), 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2cm, 1 cm, or less distance from the inner wall of the closed end. Theprotrusions 413 can be micro-protrusions. The protrusions 413 can beannular features. Alternatively or in addition, the protrusions 413 canextend with substantially even height around a cross-section perimeter(not necessarily circular or curved) of an inner surface of the vessel404. In FIG. 4, two sets of annular protrusions are illustrated. In someinstances, the protrusions 413 can be molded or otherwise integrated inthe one or more walls 412. Alternatively or in addition, the protrusions413 can be separate structures fastened to be fixed to the one or morewalls 412.

The implement 406 can be displaceable, injectable, plungeable,retractable, dejectable, ascendible, descendible, and/or otherwise bemovable or actuated relative to the vessel 404. For example, theimplement 406 can be a plunger. The implement 406 can be a secondvessel, tube or vial. The implement 406 can be a rod, stage, plate, orother actuator. Any description herein of a plunger may apply to anyother implement, such as a rod, stage, plate, or other actuator.

The implement 406 can be disposed in the cavity 414. The implement 406can be insertable in the cavity 414 towards the closed end. Theimplement 406 can comprise a protrusion 416, one or more sidewalls 418,and a second lid engagement unit 420. The one or more sidewalls 418 candefine a reservoir 422 therein for receiving a biological sample (notshown) from a user. The user may be a subject from whom the sample iscollected. The one or more sidewalls 418 can comprise one or moreopenings 424 through which the reservoir 422 and the cavity 414 are influid communication. The second lid engagement unit 420 can engage withthe second vessel engagement unit 410 of the lid 402. In some instances,the second lid engagement unit 420 can be part of the one or moresidewalls 418 of the implement. During closing of the vessel 404, thesecond vessel engagement unit 410 (e.g., protrusion) of the lid 402 canapply a force (e.g., via push, press) on the second lid engagement unit420 (e.g., sidewall perimeter) to actuate the implement 406 and injectthe implement 406 towards the closed end of the cavity 414.

The one or more sidewalls 418 of the implement 406 can comprise aprotrusion 416 towards the end of the implement 406 that is closer tothe closed end of the cavity 414. The protrusion 416 can be an annularfeature. Alternatively or in addition, the protrusion 416 can extendwith substantially even height around a cross-section perimeter (notnecessarily circular or curved) of an outer surface of the implement406. In FIG. 4, an annular protrusion is illustrated. In some instances,the protrusion 416 can be molded into or otherwise integrated as part ofthe one or more sidewalls 418. In some instances, the protrusion 416 canbe separate structures fastened and fixed on the one or more sidewalls418.

In an open position (as in FIG. 4) the protrusion 416 on the one or moresidewalls 418 of the implement 406 can engage with the one or moreprotrusions 413 on the one or more walls 412 of the vessel 404 toprovide a seal 425 between the respective walls of the implement 406 andthe vessel 404. The seal 425 can be a fluid-tight seal. The seal 425 canbe a hermetic seal. The seal 425 can be an interference seal. Forexample, the cross-section dimension (e.g., outer diameter) of theimplement 406 with the protrusion 416 can be greater than thecross-section dimension (e.g., inner diameter) of the cavity 414 withthe one or more protrusions 413. The cross-section dimension (e.g.,outer diameter) of the implement 406 with the protrusion 416 can be lessthan the cross-section dimension (e.g., inner diameter) of the cavity414 without the one or more protrusions 413 such as to allow for fluidmovement between the two cross-sections when the respective protrusionsare unengaged. In some instances, the one or more walls 412 of thevessel may comprise at least two protrusions spaced accordingly tosandwich the protrusion 416, such that the implement 406 is fixed inplace prior to application of force while providing the seal 425.

A reagent chamber 426 can be defined between the closed end of thecavity 414 and the seal 425. The reagent chamber 426 can comprise apreservation and/or stabilization reagent 460 for preserving and/orstabilizing the biological sample. The reagent chamber 426 can befluidically isolated from the remainder of the cavity 414. The reagentchamber 426 can be fluidically isolated from the reservoir 422 which isin fluid communication with the rest of the cavity 414.

When the device 400 is in an open position (as in FIG. 4), theprotrusion 416 can be engaged with the one or more protrusions 413 suchthat the seal 425 is intact and the reagent chamber 426 is fluidicallyisolated from the reservoir 422.

To alternate the device 400 to the closed position (not shown), the lid402 can be brought in proximity to the vessel 404. The first vesselengagement unit 408 (e.g., threads) in the lid 402 can engage with thefirst lid engagement unit 415 (e.g., complementary threads) in thevessel 404 to couple the lid 402 and the vessel 404. For example, thelid 402 can descend onto the vessel 404 in a threading motion. As thelid 402 descends, the second vessel engagement unit 410 (e.g.,protrusion) in the lid 402 can engage the second lid engagement unit 420(e.g., sidewall perimeter) of the implement 406, and translate thedescending motion to actuate the implement 406 and inject the implement406 towards the closed end of the cavity 414 of the vessel 402.

As the implement 406 is injected, the protrusion 416 can move past theinterference of the one or more protrusions 413, thereby disrupting theseal 425. This can bring the reagent chamber 426 in fluid communicationwith the remainder of the cavity 414 and, by extension, to the reservoir422 via the one or more openings 424. As the implement 406 is injected,and the reagent chamber 426 decreases in volume, the reagent 460 mayflow around the one or more sidewalls 418 of the implement 406 into thecavity 414 and into the reservoir 422 via the one or more openings 424to form a mixture of the biological sample (not shown) and the reagent460. The reagent 460 may preserve and/or stabilize the biological samplein the mixture.

In application, the device 400 is provided to the user in an openposition (as in FIG. 4). The reagent 460 is pre-loaded in the reagentchamber 426 and the implement 406 is disposed in the vessel 404 suchthat the protrusion 416 is engaged with the one or more protrusions 413and the seal 425 is intact. The implement 406 is insertable into thevessel 404. The user spits or otherwise deposits the biological sample(not shown) into the reservoir 422 through an opening 428 of thereservoir 422. In some instances, the opening 428 of the reservoir 422can be the only opening to the vessel 404. The biological sample and thereagent 460 are fluidically isolated.

The user can close the opening 428 of the reservoir 422 with the lid402, such as by engaging the first vessel engagement unit 408 of the lid402 and the first lid engagement unit 415 of the vessel 404. Upondescent of the lid 402 relative to the vessel 404, the second vesselengagement unit 410 of the lid 402 can engage the second lid engagementunit 420 of the implement 406, and the implement 406 can be injectedtowards the closed end of the cavity 414. Once injected, the protrusion416 moves past the one or more protrusions 413 thus becoming disengagedand the seal 425 is disrupted. The reagent chamber 426 and the remainingcavity 414 space are brought into fluid communication. As the implement406 decreases the volume of the reagent chamber 426, the reagent 460escapes the reagent chamber 426 around the one or more sidewalls 418 ofthe implement 406 to enter the remaining cavity 414 space and thereafterenter the reservoir 422 through the one or more openings 424 on the oneor more sidewalls 418 of the implement 406. The biological sample andthe reagent 460 form a mixture of the biological sample and the reagent460. The reagent 460 can preserve and/or stabilize the biological samplein the mixture. The mixture may be stored in the reservoir 422 and/orthe cavity 414.

The device 400 can be configured such that the implement 406 is fullyinjected when the lid 402 is securely fastened to the vessel 404. Whenthe implement 406 is fully injected, a tip of the implement 406 maycontact the closed end of the cavity 414 such that there issubstantially no volume in the reagent chamber 426 and as a result allof the reagent 460 comes in contact with the biological sample to formthe mixture. In some instances, the tip of the implement 406 and theclosed end of the cavity 414 can be complementary shapes or figures(e.g., conical pairs as shown in FIG. 4). Alternatively, when the lid402 is securely fastened to the vessel 404, the implement 406 may bepartially injected, and the tip of the implement 406 may not necessarilycontact the closed end of the cavity 414.

In some instances, once injected, the implement 406 can lock in theinjected position such that it cannot be dejected and the mixture staysin the reservoir 422 and/or cavity 414 space above the protrusion 416.In other instances, after injection, the implement 406 can beun-injected, such as when the lid 402 is removed and the mixture maytravel between the reservoir 422, cavity 414, and/or the reagent chamber426. In some instances, the implement 406 may not be removed from thevessel 404 by the user. For example, a cross-section of a pre-insertedpart of the implement 406 may be larger than a cross-section of the openend of the cavity 414.

Alternatively or in addition, the implement 406 may be removable fromthe vessel, such as by a lay user or lab technician.

In some instances, the seal 425 may re-seal after disruption when therespective protrusions re-engage. Alternatively, the seal 425 may remaindisrupted after the first disruption by the user. For example, the firstdisruption may or may not permanently damage (e.g., break off) the oneor more protrusions 313 or the protrusion 316.

The user may transport the closed device 400, such as via shipping, to aremote location such as an outside lab for further processing and/oranalysis. The device 400 may be shipped in a container with or withoutinsulation. For example, the container can be an envelope, packaging,and/or a box. The device 400 may withstand routine forces received inshipping environments.

In some instances, in the open position (as in FIG. 4) the reagentchamber 426 may be fully pre-loaded with the reagent 460 to fill thereagent chamber 426. Alternatively, the reagent chamber 426 may bepartially pre-loaded with the reagent 460.

In some instances, the one or more walls 412 of the vessel 404 or othercomponents of the vessel 404 and/or the implement 406 may comprise oneor more markings corresponding to fluid volume for reference to users(e.g., sample origin, lab technician, etc.) of the device 400. Forexample, one or more markings may correspond to a volume of the reagent460 in the reagent compartment 426. One or more markings may correspondto a volume of the biological sample in the reservoir 422. One or moremarking may correspond to a volume of the mixture in the reservoir 422and/or the cavity 414. In some instances, at least a part of the one ormore walls 412 of the vessel may be at least partially transparentand/or translucent, or clear, to permit visual recognition of the one ormore markings. In some instances, at least a part of the othercomponents of the vessel 404 and/or the implement 406 can be at leastpartially transparent and/or translucent, or clear, to permit visualrecognition of the one or more markings.

While FIG. 4 illustrates a device with the reservoir 422 and the reagentchamber 426 as generally vertically neighboring compartments, otherconfigurations are available. For example, the reservoir 422 and thereagent chamber 426 can be horizontally neighboring compartments,diagonally neighboring compartments, or placed relative to the other inany other orientation relative to the cavity 414.

In some instances, the user can deposit the biological sample into thereservoir 422 on a carrier. For example, the carrier can be an absorbentmember, such as a swab, cotton, pad, sponge, foam, or other material ordevice capable of carrying the biological sample by absorbing. When thereagent 460 is directed to the reservoir 422 by actuation of theimplement 306, the absorbent member may absorb the reagent 460, therebycontacting the biological sample therein with the reagent 460 topreserve and/or stabilize the biological sample. The carrier can beother materials or device capable of carrying the biological sample in alocation that is in fluid communication with the reservoir 422 such asto allow the reagent 460 to contact the biological sample on thecarrier.

In an example, the user uses the device 400 to collect the biologicalsample (e.g., saliva or cheek swab) from a subject. The user can be thesubject. Alternatively, the user can be one or more other individuals(e.g., supervisor, guardian, lab technician, worker, etc.) that collectthe biological sample from the subject. The biological sample isdeposited into the reservoir 422 through the opening 428. Next, the usercloses the vessel 404 with the lid 402, such as by engaging (e.g.,threading) the lid 402 with the vessel 404. Upon engagement, the lid 402actuates the implement 406, such as by pushing the implement 406 inwardsthe vessel 404. Actuation of the implement 406 brings the reagentchamber 426 in fluid communication with the reservoir 422. The reagent460 is directed into the reservoir 322 and forms a mixture with thebiological sample. The closed device 400 is then transported (e.g., viamail), such as to a remote lab for further processing and/or analysis.The biological sample is preserved and/or stabilized during suchtransportation with aid of the reagent 460.

Any description herein of a biological sample with reference to thedevice 400 can apply to a liquid sample. Any description herein of areagent (e.g., reagent 460) with reference to the device 400 can applyto a liquid solution. For example, the device 400 may be pre-loaded witha liquid solution and facilitate collection of a liquid sample.

FIGS. 5A-5D show another sample collection device 500. The samplecollection device 500 can comprise a lid 502, a funnel 503, a vessel504, and an implement 506. FIG. 5A shows a cross-sectional view of thesample collection device 500 with the funnel 503. FIG. 5B shows aperspective view of the funnel 503. FIG. 5C shows a cross-sectional viewof the sample collection device 500 without the funnel 503. FIG. 5Dshows a perspective view the vessel 504. The device 500 may comprise afunneled position (as in FIG. 5A), an open position (as in FIG. 5C), anda closed position (not shown).

The lid 502 can comprise a first vessel engagement unit 508 and a secondvessel engagement unit 510. The first vessel engagement unit 508, forexample, can comprise threads. The second vessel engagement unit 510,for example, can be a protrusion configured to contact one or morecomponents of the vessel 504 and/or the implement 506.

The funnel 503 can comprise a first opening 512 and a second opening514, and a fluid flow path therethrough. The funnel 503 may receive abiological sample 550 through the first opening 512 and direct thebiological sample 550 to exit the funnel 503 through the second opening514. In some instances, the first opening 512 may have a largercross-section area than a cross-section area of the second opening 514.

The funnel 503 can comprise a third vessel engagement unit 516 at ornear the second opening 514. The third vessel engagement unit 516, forexample, can be a pinching structure configured to pinch a wall of thevessel 504 and/or a wall of the implement 506. The pinching structuremay be configured to pinch together a wall of the vessel 504 and thewall of the implement 506, for example by applying a force on an innerwall of the implement 506 outwards towards an inner wall of the vessel504 and/or by applying a force on an outer wall of the vessel 504inwards towards an outer wall of the implement 506. The pinchingstructure can be a clip-like structure with two structures biased topinch. In some instances, the pinching structure can comprise an outerwall 518 and an inner wall 520 defining a cavity therebetween. The outerwall 518 and the inner wall 520 can be configured to pinch one or moreobjects (e.g., wall of the vessel 504, wall of the implement 506, etc.)disposed in the cavity. In some instances, the pinching structure maycomprise threads on the outer wall 518 and/or the inner wall 520 tofurther engage with the vessel 504.

The vessel 504 can comprise one or more walls 522 that define a cavity524 with an open end and a closed end. The one or more walls 522 cancomprise a first lid engagement unit 526 at or near the open end. Thefirst lid engagement unit 526, for example, can be threads complementaryto the first vessel engagement unit 508. The first lid engagement unit526, for example, can be threads complementary to threads on the thirdvessel engagement unit 516. The first lid engagement unit 526 may beconfigured to engage with both the first vessel engagement unit 508 onthe lid 502 and the third vessel engagement unit 516 on the funnel 503.

The one or more walls 522 of the vessel 504 can comprise one or moredepressions 528 or dents facing the inside of the cavity 524. Thedepressions 528 or dents can be micro-depressions or micro-dents. Thedepressions 528 can be annular features. Alternatively or in addition,the depressions 528 can extend with substantially even depth around across-section perimeter (not necessarily circular or curved) of an innersurface of the vessel 504. In some instances, the depressions 528 can bemolded (or carved out) or otherwise integrated in the one or more walls522.

The one or more walls 522 of the vessel 504 can comprise one or morevents 542 facing the inside of the cavity 524. The vents 542 may be adepression or dent defining a substantially vertical path from near theclosed end of the cavity 524 to near the open end of the cavity 524.

The implement 506 can be displaceable, injectable, plungeable,retractable, dejectable, ascendible, descendible, and/or otherwise bemovable or actuated relative to the vessel 504. For example, theimplement 506 can be a plunger. The implement 506 can be a secondvessel, tube or vial. The implement 506 can be a rod, stage, plate, orother actuator. Any description herein of a plunger may apply to anyother implement, such as a rod, stage, plate, or other actuator.

The implement 506 can be disposed in the cavity 524. The implement 506can be insertable in the cavity 524 towards the closed end. Theimplement 506 can comprise one or more sidewalls 532 and a second lidengagement unit 534. The one or more sidewalls 532 can define areservoir 536 therein for receiving the biological sample 550 from auser. The user may be a subject from whom the sample is collected. Theone or more sidewalls 532 can comprise one or more openings 538 throughwhich the reservoir 536 and the cavity 524 are in fluid communication.The second lid engagement unit 534 can engage with the second vesselengagement unit 510 of the lid 502. In some instances, the second lidengagement unit 534 can be part of the one or more sidewalls 532 of theimplement. During closing of the vessel 504, the second vesselengagement unit 510 (e.g., protrusion) of the lid 502 can apply a force(e.g., via push, press) on the second lid engagement unit 534 (e.g.,sidewall perimeter) to actuate the implement 506 and inject theimplement 506 towards the closed end of the cavity 524.

The one or more sidewalls 532 of the implement 506 can comprise aprotrusion 530 facing the one or more walls 522 of the vessel 504. Theprotrusion 530 can be an annular feature. Alternatively or in addition,the protrusion 530 can extend with substantially even height around across-section perimeter (not necessarily circular or curved) of an outersurface of the implement 506. In some instances, the protrusion 530 canbe molded into or otherwise integrated as part of the one or moresidewalls 532. In some instances, the protrusion 530 can be a separatestructure fastened and fixed on the one or more sidewalls 532.

In the open position (as in FIG. 5C) or the funneled position (as inFIG. 5A), the protrusion 530 on the one or more sidewalls 532 of theimplement 506 can engage with the one or more depressions 528 on the oneor more walls 522 of the vessel 504 to retain a position of theimplement 506 relative to the vessel 504. In some instances, theengagement of the protrusion 530 and the one or more depressions 528 mayprovide a seal between the respective walls of the implement 506 and thevessel 504. The seal can be a fluid-tight seal. The seal can be ahermetic seal. The seal can be an interference seal. Alternatively, theengagement of the protrusion 530 and the one or more depressions 528 maynot provide a seal.

In the funneled position (as in FIG. 5A), the funnel 503 can be fastenedto the vessel 504 upon engagement of the third vessel engagement unit516 with the vessel 504 and/or the implement 506. When engaged, at leasta part of the outer wall 518 of the funnel 503 may encompass at least aportion of the outer wall of the vessel 504 and at least a part of theinner wall 520 of the funnel 503 may be disposed within the reservoir536 such that the inner wall 520 blocks (or covers) the one or moreopenings 538 in the one or more sidewalls 532 of the implement 506. Whenengaged, the outer wall 518 and the inner wall 520 of the funnel 503 canpinch the wall of the vessel 504 and the wall of the implement 506together to provide a seal between the funnel 503 and the implement 506and between the funnel 503 and the vessel 504. The seal can be afluid-tight seal. The seal can be a hermetic seal. The seal can be aninterference seal. In the funneled position, the reservoir 536 can befluidically isolated from the cavity 524 via the seal provided by thefunnel 503.

A reagent chamber 540 can be defined between the closed end of thecavity 524 and the one or more sidewalls of the implement 506. Thereagent chamber 540 can comprise a preservation and/or stabilizationreagent 560 for preserving and/or stabilizing the biological sample 550.In the funneled position, the reagent chamber 540 can be fluidicallyisolated from the reservoir 536 via the inner wall 520 of the funnel 503blocking the one or more openings 538 in the one or more sidewalls 532of the implement 506. The reagent chamber 540 can be brought into fluidcommunication with the reservoir 536 when the device 500 is in the openposition (as in FIG. 5C) and/or the closed position (not shown) uponremoval of the funnel 503.

When the device 500 is in an open position (as in FIG. 5C), the funnel503 can be removed from the vessel 504 such as to unblock the one ormore openings 538 in the implement 506. The reagent chamber 540 can bein fluid communication with the reservoir 536. In the open position, theimplement 506 may float, or at least partially float, on the reagent560. The reagent 560 and the biological sample 550 may remain isolated,for example, due to the reagent 560 being unable to overcomegravitational forces to climb the one or more sidewalls 522 of theimplement 506 and enter the reservoir 536 through the one or moreopenings 538 and/or, similarly, the biological sample 550 being unableto overcome gravitational forces to climb the one or more sidewalls 522of the implement 506 and exit the reservoir 536 through the one or moreopenings 538.

To alternate the device 500 to the closed position (not shown) from theopen position, the lid 502 can be brought in proximity to the vessel504. The first vessel engagement unit 508 (e.g., threads) in the lid 502can engage with the first lid engagement unit 526 (e.g., complementarythreads) in the vessel 504 to couple the lid 502 and the vessel 504. Forexample, the lid 502 can descend onto the vessel 504 in a threadingmotion. As the lid 502 descends, the second vessel engagement unit 510(e.g., protrusion) in the lid 502 can engage the second lid engagementunit 534 (e.g., sidewall perimeter) of the implement 506, and translatethe descending motion to actuate the implement 506 and inject theimplement 506 towards the closed end of the cavity 524 of the vessel502.

As the implement 506 is injected, the protrusion 530 can move past theone or more depressions 528. The implement 506 may intrude the volume ofthe reagent chamber 540 and displace the reagent 560. The reagent 560may flow around the one or more sidewalls 418 of the implement 406, suchas by travelling through the one or more vents 542 in the one or morewalls 522 of the vessel 504, and enter the reservoir 536 via the one ormore openings 538. The reagent 560 and the biological sample 550 canform a mixture (not shown). The reagent 560 may preserve and/orstabilize the biological sample 550 in the mixture.

In application, the device 500 is provided to the user in the funneledposition (as in FIG. 5A). The reagent 560 is pre-loaded in the reagentchamber 540 and the implement 506 is disposed in the vessel 504 suchthat the protrusion 530 is engaged with the one or more depressions 528.The funnel 503 is engaged to the vessel 504 and the implement 506 suchthat the walls of the vessel 504 and the implement 506 are pinchedtogether, and the one or more openings 538 are blocked and sealed by thefunnel 503. The implement 506 is insertable into the vessel 504. Theuser spits or otherwise deposits the biological sample 550 into thereservoir 536 through the first opening 512 of the funnel 503. Thefunnel 503 directs the biological sample 550 out of the funnel 503through the second opening 514. The second opening 514 of the funnel isin fluid communication with an opening of the reservoir 536. In someinstances, the opening of the reservoir 536 can be the only opening tothe vessel 504. The biological sample 550 and the reagent 560 arefluidically isolated via the funnel 503.

The user can remove the funnel 503, thereby unpinching the vessel 504and the implement 506, and unsealing the one or more openings 538. Thereagent chamber 540 and the reservoir 550 are in fluid communication,but the reagent 560 and the biological sample 550 remain isolated. Theimplement 506 can at least partially float in the cavity 524 on thereagent 560.

The user can close the opening of the reservoir 536 with the lid 502,such as by engaging the first vessel engagement unit 508 of the lid 502and the first lid engagement unit 526 of the vessel 504. Upon descent ofthe lid 502 relative to the vessel 504, the second vessel engagementunit 510 of the lid 502 can engage the second lid engagement unit 534 ofthe implement 508, and the implement 506 can be injected towards theclosed end of the cavity 524. Once injected, the protrusion 530 movespast the one or more depressions 528 and intrudes the volume of thereagent chamber 540. The reagent 560 is displaced from the reagentchamber 540 by the implement 506. The reagent 560 escapes the reagentchamber 540 around the one or more sidewalls 532 of the implement 506,such as through the one or more vents 542 to enter the reservoir 536through the one or more openings 538 on the one or more sidewalls 532 ofthe implement 506. The biological sample 550 and the reagent 560 form amixture of the biological sample 550 and the reagent 560. The reagent560 can preserve and/or stabilize the biological sample 550 in themixture.

The device 500 can be configured such that the implement 506 is fullyinjected when the lid 502 is securely fastened to the vessel 504. Whenthe implement 506 is fully injected, a tip of the implement 506 maycontact the closed end of the cavity 524 such that there issubstantially no volume in the reagent chamber 540 and as a result allof the reagent 560 comes in contact with the biological sample 550 toform the mixture. In some instances, the tip of the implement 506 andthe closed end of the cavity 524 can be complementary shapes or figures(e.g., conical pairs as shown in FIG. 5C). Alternatively, when the lid502 is securely fastened to the vessel 504, the implement 506 may bepartially injected, and the tip of the implement 506 may not necessarilycontact the closed end of the cavity 524.

In some instances, once injected, the implement 506 can lock in theinjected position such that it cannot be dejected and the mixture staysin the reservoir 536 and/or cavity 524 space between the implement 506and the vessel 504. In other instances, after injection, the implement506 can be un-injected, such as when the lid 502 is removed and themixture may travel between the reservoir 536, the cavity 524, and/or thereagent chamber 540. In some instances, the implement 506 may not beremoved from the vessel 504 by the user. For example, a cross-section ofa pre-inserted part of the implement 506 may be larger than across-section of the open end of the cavity 524. Alternatively or inaddition, the implement 506 may be removable from the vessel, such as bya lay user or lab technician.

The user may transport the closed device 500, such as via shipping, to aremote location such as an outside lab for further processing and/oranalysis. The device 500 may be shipped in a container with or withoutinsulation. For example, the container can be an envelope, packaging,and/or a box. The device 500 may withstand routine forces received inshipping environments.

In some instances, in the funneled position the reagent chamber 540 maybe fully pre-loaded with the reagent 560 to fill the reagent chamber540. Alternatively, the reagent chamber 540 may be partially pre-loadedwith the reagent 560.

In some instances, the one or more walls 522 of the vessel 504 or othercomponents of the vessel 504 and/or the implement 506 may comprise oneor more markings corresponding to fluid volume for reference to users(e.g., sample origin, lab technician, etc.) of the device 500. Forexample, one or more markings may correspond to a volume of the reagent560 in the reagent compartment 540. One or more markings may correspondto a volume of the biological sample 550 in the reservoir 536. One ormore marking may correspond to a volume of the mixture in the reservoir536 and/or the cavity 524. In some instances, at least a part of the oneor more walls 522 of the vessel 504 may be at least partiallytransparent and/or translucent, or clear, to permit visual recognitionof the one or more markings. In some instances, at least a part of theother components of the vessel 504 and/or the implement 506 can be atleast partially transparent and/or translucent, or clear, to permitvisual recognition of the one or more markings.

While FIG. 5 illustrates a device with the reservoir 536 and the reagentchamber 540 as generally vertically neighboring compartments, otherconfigurations are available. For example, the reservoir 536 and thereagent chamber 540 can be horizontally neighboring compartments,diagonally neighboring compartments, or placed relative to the other inany other orientation relative to the cavity 524.

In some instances, the user can deposit the biological sample 550 intothe reservoir 536 on a carrier. For example, the carrier can be anabsorbent member, such as a swab, cotton, pad, sponge, foam, or othermaterial or device capable of carrying the biological sample byabsorbing. When the reagent 560 is directed to the reservoir 536 byactuation of the implement 506, the absorbent member may absorb thereagent 560, thereby contacting the biological sample 550 therein withthe reagent 560 to preserve and/or stabilize the biological sample 550.The carrier can be other materials or device capable of carrying thebiological sample 550 in a location that is in fluid communication withthe reservoir 536 such as to allow the reagent 560 to contact thebiological sample 550 on the carrier.

In an example, the user uses the device 500 to collect the biologicalsample (e.g., saliva or cheek swab) from a subject. The user can be thesubject. Alternatively, the user can be one or more other individuals(e.g., supervisor, guardian, lab technician, worker, etc.) that collectthe biological sample from the subject. The user receives the device 500in the funneled position. The biological sample is deposited into thereservoir 536 through the first opening 512 of the funnel 503. Next, theuser removes the funnel 503. Next, the user closes the vessel 504 withthe lid 502, such as by engaging (e.g., threading) the lid 502 with thevessel 504. Upon engagement, the lid 502 actuates the implement 506,such as by pushing the implement 506 inwards the vessel 504. Actuationof the implement 506 displaces the reagent 560 in the reagent chamber540. The reagent 560 is directed through the vents 542 and the one ormore openings 538 into the reservoir 536. The reagent 560 forms amixture with the biological sample 550. The closed device 500 is thentransported (e.g., via mail), such as to a remote lab for furtherprocessing and/or analysis. The biological sample is preserved and/orstabilized during such transportation with aid of the reagent 560.

Any description herein of a biological sample (e.g., biological sample550) with reference to the device 500 can apply to a liquid sample. Anydescription herein of a reagent (e.g., reagent 560) with reference tothe device 500 can apply to a liquid solution. For example, the device500 may be pre-loaded with a liquid solution and facilitate collectionof a liquid sample.

FIG. 6A shows a cross-sectional view of another sample collection device600 in an open position. FIG. 6B shows a cross-sectional view of thesample collection device 600 in a closed position. The sample collectiondevice 600 can comprise a vessel 602 and a lid 604.

The vessel 602 can comprise one or more walls 606 that define areservoir 608 for receiving a biological sample 650 from a user. Theuser may be a subject from whom the sample is collected. The one or morewalls 606 can comprise a lid engagement unit 610, such as threads, tocouple with the lid 604. The vessel 602 can comprise rim 612, such as toact as a stopping guide for the lid 604.

The lid 604 can comprise an outer shell 614 and an inner wall 616. Theouter shell 614 can comprise a vessel engagement unit 618, such ascomplementary threads to the lid engagement unit 610.

The inner wall 616 can be mechanically assembled to the outer shell 614.The inner wall 616 and the outer shell 614 can define a reagent chamber620. The reagent chamber 620 can comprise an absorbent member 622 (A,B). The absorbent member 622 can have absorbed therein a preservationand/or stabilization reagent 660 for preserving and/or stabilizing thebiological sample 650. The absorbent member 622 can be compressible(e.g., deformable). For example, the absorbent member 622 can have atleast an uncompressed state 622A and a compressed state 622B. Theabsorbent member 622 can be an absorbent matrix, such as an air matrixor a fiber matrix. The absorbent matrix can be porous. The absorbentmember can be formed of a polymeric material. For example, the absorbentmember is formed of an absorbent matrix that includes a polymericmaterial (e.g., poly(vinyl formal) (PVF), polypropylene (PP), (PTFE),polyethylene terephthalate (PET) polyester, polyurethane, ethylene vinylalcohol, polyvinyl alcohol, polycaprolactone, polylactic acid, starch,etc.). For example, the absorbent member 622 can be a foam or sponge.The absorbent member 622 can be open cell or closed cell foam. In someinstances, in the uncompressed state 622A, the absorbent member 622 mayretain the reagent 660 absorbed therein without spillage or leakage,such as via capillary action and/or other adhesive/cohesive forces. Insome instances, the quantity of reagent 660 loaded into the absorbentmember 622 can be controlled for secure containment in the uncompressedstate 622A. At least some of the reagent 660 in the absorbent member 622may exit (e.g., flow out of) the absorbent member 622 upon compression,such as in the compressed state 622B.

When mechanically assembled, the inner wall 616 may move with somedegree of freedom relative to the outer shell 614. For example, theinner wall 616 may be capable of moving inwards into the reagentcompartment 620 to compress the absorbent member 622. The inner wall 616can comprise an aperture 624 through which the reagent 660 may leave thereagent chamber 620.

In an open position (as in FIG. 6A), the inner wall 616 may be disposedrelative to the outer shell 614 such the absorbent member 622 in thereagent chamber 620 is in an uncompressed state 622A. The reagentchamber 620 can be in fluid communication with spaces external to thereagent chamber 620 via the aperture 624 in the inner wall 616. Thereagent 620 absorbed in the absorbent member 622 may remain contained inthe absorbent member 622 in the reagent chamber 620.

To alternate to the closed position (as in FIG. 6B), the vessel 602 canbe closed with the lid 604 by coupling the vessel engagement unit 618with the first lid engagement unit 610, such as via a threading motion.Alternatively, other coupling or fastening mechanisms describedelsewhere herein may be applied, such as using form-fitting structures,snaps, latches, and/or other fasteners. As the lid 604 descends to coverthe vessel 602, the inner wall 616 can engage with the one or more walls612 of the vessel, such as the top perimeter of the sidewalls. Acontinued descending motion can push the inner wall 612 into the reagentchamber 620. The absorbent member 622 can compress, such as tocompressed state 622B, to accommodate the decreasing volume of thereagent chamber 620. The reagent 660 contained therein the absorbentmember 622 may flow out of the absorbent member 622 and into thereservoir 608 which is in fluid communication with the reagent chamber620 via the aperture 624. The reagent 660 can contact the biologicalsample 650 in the reservoir 608 to form a mixture 670 with thebiological sample 650. The biological sample 650 can thereby bepreserved and/or stabilized in the mixture 670.

In application, the user is provided the device 600 in an open position(as in FIG. 6A). The reagent 660 is pre-loaded in the absorbent member622 in the reagent chamber 620 in the lid 604. The inner wall 616 andthe outer shell 614 are mechanically assembled such that the inner wall614 is not compressing the absorbent member 622. The absorbent member622 is in the uncompressed state 622A, and the reagent 660 may becontained therein without leakage. The user spits or otherwise depositsthe biological sample 650 into the reservoir 608 through an opening ofthe reservoir 608 in the vessel 602.

The user can close the vessel 602 with the lid 604. As the lid 604 isbrought in proximity to the vessel 602, the lid engagement unit 610(e.g., threads) in the vessel 602 engages the vessel engagement unit 618(e.g., complementary threads) in the lid 604. The lid 604 descendsrelative to the vessel 602 until the inner wall 616 engages the top ofthe one or more walls 505 of the vessel 602. As the lid 604 continues todescend relative to the vessel 602, the inner wall 616 is pushed intothe reagent chamber 620 to compress the absorbent member 622. In thecompressed state 622B, the absorbent member 622 releases the reagent 660absorbed therein. The reagent 660 flows into the reservoir 608 via theaperture 624 to form a mixture 670 of the reagent 660 and the biologicalsample 650. The biological sample 650 can thereby be preserved and/orstabilized in the mixture 670. In some instances, the reagent 660 mayflow into the reservoir 608 via gravitational forces.

Thereafter, the lid 604 is fastened to the vessel 602 and the mixture670 is confined in the reservoir 608 and optionally in the reagentcompartment 620 which is in fluid communication with the reservoir 608.

The user may transport the closed device 600, such as via shipping, to aremote location such as an outside lab for further processing and/oranalysis. The device 600 may be shipped in a container with or withoutinsulation. For example, the container can be an envelope, packaging,and/or a box. The device 600 may withstand routine forces received inshipping environments.

In some instances, the user can deposit the biological sample 650 intothe reservoir 608 on a carrier. For example, the carrier can be anabsorbent device, such as a swab, cotton, pad, sponge, foam, or othermaterial or device capable of carrying the biological sample 650 byabsorbing. When the reagent 660 flows in the reservoir 608, theabsorbent device may absorb the reagent 660, thereby contacting thebiological sample 650 therein with the reagent 660 to preserve and/orstabilize the biological sample 650. The carrier can be other materialsor devices capable of carrying the biological sample 650 in a locationthat is in fluid communication with the reservoir 608 such as to allowthe reagent 660 to contact the biological sample 650 on the carrier.

In some instances, the inner wall 616 and the outer shell 614 may bemechanically assembled such that the inner wall 616 may move relative tothe outer shell 614 with a limited degree of freedom. For example, theinner wall 616 may move relative to the outer shell 614 by at most 10centimeters (cm), 9 cm, 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm,0.5 cm, or less. Alternatively, the inner wall 616 may move relative tothe outer shell 614 by more than 10 cm. In some instances, the innerwall 616 and the outer shell 614 may be mechanically assembled such thatthe inner wall 616 may move relative to the outer shell 614 in limiteddirections (e.g., 1 axis, 2 axes, 3 axes, etc.). Alternatively, theinner wall 616 and the sleeve 614 may be mechanically assembled suchthat the inner wall 616 may move relative to the outer shell 614 in anydirection.

In some instances, the inner wall 620 can comprise a plurality ofapertures, such as 2, 3, 4, 5, 6, 7, 8, 9, 20, or more apertures. Insome instances, the inner wall 620 can comprise a mesh.

In some instances, in the open position (as in FIG. 6A) the uncompressedabsorbent member 622A may be fully pre-loaded (e.g., saturated) with thereagent 660. Alternatively, the uncompressed absorbent member 622A maybe partially pre-loaded with the reagent 660. For example, the absorbentmember 622 can be at least about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%,10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, 91%,92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% saturated or higher.Alternatively or in addition, the absorbent member 622 can be at mostabout 99%, 98%, 97%, 96%, 95%, 94%, 93%, 92%, 91%, 90%, 80%, 70%, 60%,50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%,2%, 1% saturated or lower. Alternatively or in addition, the absorbentmember 622 can be saturated by less than 1% or more than 99%.

In some instances, the one or more walls 606 of the vessel 602 maycomprise one or more markings corresponding to fluid volume forreference to users (e.g., sample origin, lab technician, etc.) of thedevice 600. For example, one or more markings may correspond to a volumeof the biological sample 650 in the reservoir 608. One or more markingmay correspond to a volume of the mixture 670 in the reservoir 608. Insome instances, at least a part of the one or more walls 606 of thevessel 602 may be at least partially transparent and/or translucent, orclear, to permit visual recognition of the one or more markings. In someinstances, the outer shell 614 of the lid 604 may comprise one or moremarkings corresponding to fluid volume for reference to users (e.g.,sample origin, lab technician, etc.) of the device 600. For example, oneor more markings may correspond to a volume of the reagent 660 or aheight of the absorbent member 622 in the reagent compartment 210. Insome instances, at least a part of the outer shell 614 of the lid 604may be at least partially transparent and/or translucent, or clear, topermit visual recognition of the one or more markings.

In some instances, the inner wall 616 may comprise a flexible material.In some instances, the inner wall 616 may be a pierceable, puncturable,tearable, and/or otherwise breakable membrane or barrier that pierces,punctures, tears, and/or breaks when the inner wall 616 engages the sidewalls of the vessel 602.

In an example, the user uses the device 600 to collect the biologicalsample 650 (e.g., saliva or cheek swab) from a subject. The user can bethe subject. Alternatively, the user can be one or more otherindividuals (e.g., supervisor, guardian, lab technician, worker, etc.)that collect the biological sample 650 from the subject. The biologicalsample 650 is deposited into the reservoir 608. Next, the user closesthe vessel 602 with the lid 604, such as by engaging (e.g., threading)the lid 604 with the vessel 602. Upon engagement, the inner wall 616 ispushed inwards towards the reagent chamber 620, compressing theabsorbent member 622. Upon compression, the reagent 660 that wasabsorbed in the absorbent member 622 is released from the absorbentmember 622 and directed into the reservoir 608 through the aperture 624,and forms a mixture 670 with the biological sample 650. The closeddevice 600 is then transported (e.g., via mail), such as to a remote labfor further processing and/or analysis. The biological sample 650 ispreserved and/or stabilized during such transportation with aid of thereagent 660.

Any description herein of a biological sample (e.g., biological sample650) with reference to the device 600 can apply to a liquid sample. Anydescription herein of a reagent (e.g., reagent 660) with reference tothe device 600 can apply to a liquid solution. For example, the device600 may be pre-loaded with a liquid solution and facilitate collectionof a liquid sample.

In some instances, one or more portions of a sample collection devicemay be made of any suitable plastics, such as polypropylene,polystyrene, and/or polycarbonate. For example, an outer component, suchas the vessel body and the lid body (e.g., outer shell) may be made ofone or more plastics. Alternatively or in addition, one or more portionsof the sample collection device may be made of metallic material (e.g.,aluminum, etc.), or composite material.

Individual components within the sample collection device (e.g.,plunger, protrusions, etc.) may comprise the same or different materialsas the body of the device suited for the function of the individualcomponents. The sample collection device may comprise a materialresistant (e.g., chemically non-reactive) to the reagent containedtherein.

The sample collection device may have varying dimensions. In someinstances, the sample collection device may have dimensions smaller thanabout a standard 500 mL water bottle. In some instances, a closed samplecollection device may have a maximum dimension of at most about 20centimeters (cm), 18 cm, 16 cm, 14 cm, 12 cm, 10 cm, 9 cm, 8 cm, 7 cm, 6cm, 5 cm, 4 cm, 3 cm, 2 cm, 1 cm or less. Alternatively, a closed samplecollection device may have a maximum dimension greater than about 20 cm.In some cases, the closed sample collection device may have a lengthfrom about 6 cm to about 15 cm. Alternatively, the closed samplecollection device may have a length less than about 6 cm or greater thanabout 15 cm. In some instances, the device may have a maximumcross-section diameter (e.g., not the length) of about 7 cm, 6 cm, 5 cm,4 cm, 3 cm, 2 cm, 1 cm or less. Alternatively, the device may have amaximum cross-section diameter of greater than about 7 cm. In somecases, the device may have an outer diameter from about 1 cm to about 2cm. Alternatively, the device may have an outer diameter less than about1 cm or greater than about 2 cm. In some instances, a reservoir forreceiving a biological sample can have volume dimensions of at mostabout 200 milliliters (mL), 150 mL, 100 mL, 95 mL, 90 mL, 85 mL, 80 mL,75 mL, 70 mL, 65 mL, 60 mL, 55 mL, 50 mL, 45 mL, 40 mL, 35 mL, 30 mL, 25mL, 20 mL, 15 mL, 10 mL, 5 mL, 4 mL, 3 mL, 2 mL, 1 mL or less.Alternatively, the reservoir can have volume dimensions greater thanabout 200 mL. In some instances, a reagent compartment in a vessel canhave volume dimensions of at most about 200 milliliters (mL), 150 mL,100 mL, 95 mL, 90 mL, 85 mL, 80 mL, 75 mL, 70 mL, 65 mL, 60 mL, 55 mL,50 mL, 45 mL, 40 mL, 35 mL, 30 mL, 25 mL, 20 mL, 15 mL, 10 mL, 5 mL, 4mL, 3 mL, 2 mL, 1 mL or less. Alternatively, the reagent compartment ina vessel can have volume dimensions greater than about 200 mL. In someinstances, a reagent compartment in a lid can have volume dimensions ofat most about 200 milliliters (mL), 150 mL, 100 mL, 95 mL, 90 mL, 85 mL,80 mL, 75 mL, 70 mL, 65 mL, 60 mL, 55 mL, 50 mL, 45 mL, 40 mL, 35 mL, 30mL, 25 mL, 20 mL, 15 mL, 10 mL, 5 mL, 4 mL, 3 mL, 2 mL, 1 mL or less.Alternatively, the reagent compartment in a lid can have volumedimensions greater than about 200 mL.

Any embodiment of a sample collection device described herein maycomprise from about 0.1 mL to about 5 mL, from about 0.1 mL to about 10mL, from about 0.1 mL to about 100 mL, from about 5 mL to about 10 mL,from about 5 mL to about 100 mL, from about 10 mL to about 100 mL, orother ranges of the reagent. The sample collection device may compriseless than 0.1 mL of the reagent. The sample collection device maycomprise more than about 100 mL of the reagent. In some instances, aboutan equal volume of each of the biological sample and the reagent can bemixed together, such as within 0.1 mL difference, 1 mL difference, or 10mL difference of each other.

The sample collection device may be used by a subject from whom thebiological sample originates. The sample collection device may be usedby an unsophisticated user with or without direct supervision. Thesample collection device may be used by a non-subject, such as atechnician, guardian, parent, or other individual, to collect thesubject's biological sample.

While different embodiments have been shown and described separately,components of different embodiments may be used in various combinations.By way of example, the absorbent member 622 in the reagent chamber 620in FIGS. 5A and 5B may also be located in the reagent chamber 110 inFIG. 1A, the reagent chamber 326 in FIGS. 3A and 3B, and/or the reagentchamber 426 in FIG. 4.

Kit

In some instances, the sample collection device may be provided as partof a kit. The kit can be a sample collection kit. The kit can be asample processing kit. The kit can be a sample collection and processingkit. The kit may be provided to a user. In some instances, the user maybe a subject from whom the sample is collected. In some instances, theuser may be a supervisor, guardian, or assistant of the subject. In someinstances, the user may be a lab personnel (e.g., technician, operator,etc.) receiving a sample from the subject.

The kit can comprise one or more sample collection devices as describedelsewhere herein. The kit can comprise instructions or a set ofinstructions for sample collection and/or sample processing. Theinstructions may be directed to non-sophisticated users, includingminors, and/or sophisticated users. The instructions may instruct on howto use a sample collection device, collect a sample using the device,dispose (e.g., ship to a remote location) of the device after use,access results from analysis of the sample, or other instructions. Theinstructions may provide safety instructions. The instructions can bepictorial. In some instances, the instructions may instruct on how toretrieve a sample from a sample collection device. In some instances,the instructions may instruct on how to process the sample retrievedfrom a sample collection device.

The kit can comprise one or more containers for shipping the one or moresample collection devices to a remote location, such as a remote lab forfurther processing and/or analysis. For example, the one or morecontainers can be boxes, envelopes, and/or other packaging material(e.g., insulating material, self-sealing or other sealing mechanism,postage, etc.). The kit can comprise a return label and/or a prepaidlabel, such as for use with a mail, shipping, and/or a carrier service.The collected sample may be transported, such as via shipping (e.g.,through the mail or a carrier), to a remote lab for further processingand/or analysis.

Sample Processing

Another aspect provides methods for collecting a sample from a subject,receiving the sample and processing the sample. The sample may becollected using any of the sample collection devices provide herein. Thesample may be collected from the subject. In an example, the subject mayuse the sample collection device to collect the sample from the subjectdirectly. As an alternative, another individual (e.g., laboratorytechnician, nurse, or physician) may use the sample collection device tocollect the sample from the subject. The sample collection devicesprovided herein may retain and/or store the collected sample until thesample is retrieved for further processing and/or analysis.

The collected sample can be transported to a processing center, such asa laboratory or research facility. The processing center can be remotefrom a point of collection. The collected sample can be transported viashipping (e.g., through the mail or a carrier). During transportation,the sample can be preserved and/or stabilized with aid of the reagentsin the sample collection device. The sample may be preserved and/orstabilized on the order of hours, days, weeks, months, and/or yearsduring transportation and/or storage. A sample collection devicecomprising the collected sample may be received at the processingcenter. The sample may be retrieved from the sample collection deviceand processed.

Processing may include nucleic acid amplification, such as viapolymerase chain reaction (PCR). The nucleic acid amplification caninvolve thermal cycling, such as the reiterative cycling of a reactioncocktail between different reaction temperatures. Thermal cyclingconditions (e.g., number of thermal cycles, temperatures utilized, cycletime, total run time, etc.) can be controlled to change the differentparameters of amplification products. The nucleic acid amplification canbe an isothermal amplification. Isothermal amplification can involveamplification at a single and constant temperature or single andconstant range of temperature.

Processing may include obtaining sequencing information. Sequencing caninclude methods and technologies for determining the sequence ofnucleotide bases in one or more polynucleotides. The polynucleotides canbe, for example, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA),including variants or derivatives thereof (e.g., single stranded DNA).

Sequencing may involve digital PCR. Sequencing can be performed byvarious systems currently available, such as, without limitation, asequencing system by Illumina, Pacific Biosciences, Oxford Nanopore, orLife Technologies (Ion Torrent). Sequencing may be next generationsequencing (e.g., Illumina or Pacific Biosciences of California).Sequencing may use a probe array, such as a gene chip (e.g., Affymetrixgene chip). Sequencing may be massively parallel array sequencing (e.g.,Illumina) and/or single molecule sequencing (e.g., Oxford Nanopore).Such devices may provide a plurality of raw genetic data correspondingto the genetic information of a subject (e.g., humans), as generated bythe device from a sample provided by the subject. Alternatively or inaddition, processing may include proteomic information.

Processing can yield data. The data may be sequencing data. The data maybe proteomic data. The processed data may be analyzed to provide anoutput. The output may be in the form of a report. The report may be anelectronic report. The report may be delivered to the subject or anotheruser (e.g., healthcare provider) electronically, such as via electronicmail. The report may be delivered to the subject, over one or moreservers and/or networks, such as via a web interface.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. It is not intendedthat the invention be limited by the specific examples provided withinthe specification. While the invention has been described with referenceto the aforementioned specification, the descriptions and illustrationsof the embodiments herein are not meant to be construed in a limitingsense. Numerous variations, changes, and substitutions will now occur tothose skilled in the art without departing from the invention.Furthermore, it shall be understood that all aspects of the inventionare not limited to the specific depictions, configurations or relativeproportions set forth herein which depend upon a variety of conditionsand variables. It should be understood that various alternatives to theembodiments of the invention described herein may be employed inpracticing the invention. It is therefore contemplated that theinvention shall also cover any such alternatives, modifications,variations or equivalents. It is intended that the following claimsdefine the scope of the invention and that methods and structures withinthe scope of these claims and their equivalents be covered thereby.

What is claimed is:
 1. A device for storing a liquid sample, comprising:one or more walls defining a reservoir for receiving said liquid sample,wherein said reservoir comprises an opening for receiving and storingsaid liquid sample and an aperture; a reagent chamber for storing aliquid solution, wherein said reagent chamber is in controllable fluidcommunication with said reservoir through said aperture; and a plungercomprising a first part and a second part, said first part carrying alower gasket and said second part carrying an upper gasket, wherein saidplunger is configured to be movable between a first position and asecond position in which said plunger is configured to be furtherinserted into said reservoir compared to said first position, wherein(i) at said first position, said upper gasket of said second part ofsaid plunger is configured to seal said aperture from a side of saidreservoir, and (ii) at said second position, said upper gasket isconfigured to be positioned away from said aperture and said lowergasket of said first part of said plunger is configured to seal saidaperture from a side of said reagent chamber, wherein said plunger isconfigured to push said liquid solution from said reagent chamberthrough said aperture to said reservoir during movement of said plungerfrom said first position to said second position.
 2. The device of claim1, further comprising a lid for closing said opening.
 3. The device ofclaim 1, wherein said reagent chamber comprises a second opening forreceiving said liquid solution, and wherein said lower gasket isconfigured to seal said second opening during said movement of saidplunger from said first position to said second position.
 4. The deviceof claim 3, wherein the device is configured such that a mixture of saidliquid sample and said liquid solution is retained in said reservoirwhen said plunger is at said second position.
 5. The device of claim 3,wherein a diameter of said second opening is greater than or equal to adiameter of said aperture.
 6. The device of claim 1, wherein, at saidfirst position, said reagent chamber comprises said liquid solution inan amount that partially fills said reagent chamber.
 7. The device ofclaim 1, wherein said plunger is configured to lock at said secondposition.
 8. The device of claim 1, wherein said liquid sample is abiological sample.
 9. The device of claim 8, wherein said liquidsolution is a reagent for stabilizing said biological sample.
 10. Thedevice of claim 1, further comprising a container for shipping saiddevice, where said container comprises a cavity that is dimensioned toreceive and retain said device during said shipping.
 11. The device ofclaim 1, wherein said reagent chamber comprises a second opening forreceiving said liquid solution, and wherein said lower gasket isconfigured to seal said second opening when said plunger is at saidfirst position and at said second position.
 12. The device of claim 11,wherein said first part of said plunger comprises a pre-inserted portionwith a diameter greater than a diameter of said second opening, andwherein said pre-inserted portion of said first part of said plunger isinside of said reagent chamber at said first position and at said secondposition.
 13. The device of claim 12, wherein said plunger is fixed insaid device.